Moderna
Associate Director, Global Regulatory Strategy, Oncology
Moderna, Cambridge, Maryland, United States, 21613
Associate Director, Global Regulatory Strategy, Oncology page is loaded
Associate Director, Global Regulatory Strategy, Oncology
Apply locations Cambridge, Massachusetts USA - New Jersey - Princeton - 5 Vaughn Drive time type Full time posted on Posted 22 Days Ago job requisition id R16556
The Role: Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Modernas US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets. The Associate Director will be a strategic leader within the Global Regulatory Strategy, Oncology group. They will be responsible for developing and executing regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development. They will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is strongly desired. Heres What Youll Do: Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL
Sets strategic direction for the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned programs.
Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
Leads the strategy for US FDA interactions with the cross functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements.
In collaboration with the cross functional team, leads the response to health authority requests for additional data, organizes and manages participation in meetings relevant to aspects of compound development
Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).
Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.
May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.
Identify areas in need of improvement and lead the development and implementation of process improvements.
Heres What Youll Bring to the Table: BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred
7+ years of experience in the Pharmaceutical industry preferred
5+ years of experience in Regulatory strategy or relevant training/experience preferred
Experience in oncology therapeutics highly preferred
Demonstrated track record in being a leader on functional and cross-functional teams
Strong knowledge of current US regulations and knowledge of ex-US regulations
Strong experience with CTD format and content of regulatory filings
Exceptional written and oral communication
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US
Demonstrate strong organizational skills, including the ability to prioritize workload.
Experience in developing regulatory strategies at various drug development time points
Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
Experience in authoring regulatory documents
Knowledge and understanding of applicable regulations.
Experience working on products across all stages of product development.
At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-KF1
- About Us
Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the bodys cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission : To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision : To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. #J-18808-Ljbffr
Apply locations Cambridge, Massachusetts USA - New Jersey - Princeton - 5 Vaughn Drive time type Full time posted on Posted 22 Days Ago job requisition id R16556
The Role: Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Modernas US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets. The Associate Director will be a strategic leader within the Global Regulatory Strategy, Oncology group. They will be responsible for developing and executing regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development. They will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is strongly desired. Heres What Youll Do: Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL
Sets strategic direction for the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned programs.
Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
Leads the strategy for US FDA interactions with the cross functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements.
In collaboration with the cross functional team, leads the response to health authority requests for additional data, organizes and manages participation in meetings relevant to aspects of compound development
Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).
Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.
May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.
Identify areas in need of improvement and lead the development and implementation of process improvements.
Heres What Youll Bring to the Table: BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred
7+ years of experience in the Pharmaceutical industry preferred
5+ years of experience in Regulatory strategy or relevant training/experience preferred
Experience in oncology therapeutics highly preferred
Demonstrated track record in being a leader on functional and cross-functional teams
Strong knowledge of current US regulations and knowledge of ex-US regulations
Strong experience with CTD format and content of regulatory filings
Exceptional written and oral communication
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US
Demonstrate strong organizational skills, including the ability to prioritize workload.
Experience in developing regulatory strategies at various drug development time points
Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
Experience in authoring regulatory documents
Knowledge and understanding of applicable regulations.
Experience working on products across all stages of product development.
At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-KF1
- About Us
Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the bodys cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission : To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision : To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. #J-18808-Ljbffr