Annexon Bioscience
Vice President, Regulatory Affairs
Annexon Bioscience, San Francisco, California, United States, 94199
At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.
For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
We're seeking exceptional talent
from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.Learn more about our commitment to diversity, equity, inclusion, and our company culture ! Position: This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative and novel programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with global regulatory agencies to support development and registration strategies. The Vice President, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements. Responsibilities include: Provides regulatory leadership and strategic direction in support of the development, registration, and life-cycle management of Annexon products including collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, Manufacturing and Quality to define and implement global regulatory strategies for Annexon’s novel assets across IND/CTA, NDA/BLA or MAA filings in US, EU, and other regions. Lead the preparation and submission of INDs, CTAs, briefing packages, DSURs, IBs, and marketing applications, including representing Regulatory on Program Core Teams as applicable. Serve as primary point of contact for FDA, EMA, PMDA, and other authorities, as required. Manage meetings, negotiations, and correspondence. Mentor and develop a small regulatory affairs team, including outside consultants; establish SOPs, regulatory systems, and performance metrics. Translate regulatory risks into actionable recommendations for product development and business strategy. Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s) Manage regulatory budget and external consultants/CRO relationships, including submission vendors, as required. Support due diligence and business development teams on regulatory risk assessments. Other duties as required. Education, Experience, and Skills: Required: PhD/PharmD with 15+ years’ experience in Regulatory Affairs or BS/MS/MSN with 18+ years’ experience. Experience in a successful leadership role with a proven track record of regulatory submissions to FDA, EMA, and/or international agencies. Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD Capable both as a strategic leader and hands on contributor in a fast-paced small company environment. Superior scientific writing skills for developing regulatory documents. Understands the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements. Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings. Experience with small and large molecules and rare diseases. Develops and maintains strong collaborative internal and external working relationships. Possesses a thorough knowledge of current FDA regulations and guidance of requirements for investigational products, IND/NDA submission requirements, and CMC information. Must be able to generate regulatory strategies and provide leadership to multidisciplinary teams. Possesses leadership skills and ability to interact with outside vendors and partner companies. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player. Preferred: Experience within the ophthalmology domain is a plus Salary Range: $306,000 to $340,000 Location:
This is an on-site position located at Annexon Headquarters in Brisbane, California. A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance. Shuttle service from BART, CalTrain and the Ferry. Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. Annexon Biosciences
is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported.
We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. Create a Job Alert Interested in building your career at Annexon Biosciences? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Address Line 1 * Address Line 2 City * State * Select... Postal Code * Preferred Name Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Annexon Biosciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
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from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.Learn more about our commitment to diversity, equity, inclusion, and our company culture ! Position: This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative and novel programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with global regulatory agencies to support development and registration strategies. The Vice President, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements. Responsibilities include: Provides regulatory leadership and strategic direction in support of the development, registration, and life-cycle management of Annexon products including collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, Manufacturing and Quality to define and implement global regulatory strategies for Annexon’s novel assets across IND/CTA, NDA/BLA or MAA filings in US, EU, and other regions. Lead the preparation and submission of INDs, CTAs, briefing packages, DSURs, IBs, and marketing applications, including representing Regulatory on Program Core Teams as applicable. Serve as primary point of contact for FDA, EMA, PMDA, and other authorities, as required. Manage meetings, negotiations, and correspondence. Mentor and develop a small regulatory affairs team, including outside consultants; establish SOPs, regulatory systems, and performance metrics. Translate regulatory risks into actionable recommendations for product development and business strategy. Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s) Manage regulatory budget and external consultants/CRO relationships, including submission vendors, as required. Support due diligence and business development teams on regulatory risk assessments. Other duties as required. Education, Experience, and Skills: Required: PhD/PharmD with 15+ years’ experience in Regulatory Affairs or BS/MS/MSN with 18+ years’ experience. Experience in a successful leadership role with a proven track record of regulatory submissions to FDA, EMA, and/or international agencies. Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD Capable both as a strategic leader and hands on contributor in a fast-paced small company environment. Superior scientific writing skills for developing regulatory documents. Understands the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements. Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings. Experience with small and large molecules and rare diseases. Develops and maintains strong collaborative internal and external working relationships. Possesses a thorough knowledge of current FDA regulations and guidance of requirements for investigational products, IND/NDA submission requirements, and CMC information. Must be able to generate regulatory strategies and provide leadership to multidisciplinary teams. Possesses leadership skills and ability to interact with outside vendors and partner companies. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player. Preferred: Experience within the ophthalmology domain is a plus Salary Range: $306,000 to $340,000 Location:
This is an on-site position located at Annexon Headquarters in Brisbane, California. A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance. Shuttle service from BART, CalTrain and the Ferry. Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. Annexon Biosciences
is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported.
We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. Create a Job Alert Interested in building your career at Annexon Biosciences? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Address Line 1 * Address Line 2 City * State * Select... Postal Code * Preferred Name Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Annexon Biosciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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