Exelixis
CMC Regulatory Dossier Management Director
Exelixis, Alameda, California, United States, 94501
SUMMARY / JOB PURPOSE
This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. Responsible and accountable for leading the development of high‑quality, phase‑appropriate regulatory sections and delivering documents to regulatory operations on an aligned timeline. Responsible for developing strategy and supporting materials to support PSC related health authority interactions. Manages submissions to US investigational new drug applications (IND), ex‑US clinical trial applications, and Biologics License Applications (BLAs) and ex‑US licence applications. This role works closely with the Bio CMC (Chemistry, Manufacturing and Controls (CMC)), Regulatory Affairs CMC, and Quality Assurance departments, as well as with cross‑functional project teams.
ESSENTIAL DUTIES/RESPONSIBILITIES
Lead development of high‑quality, phase‑appropriate CMC‑related submissions to regulatory authorities and regulatory affairs, tracking progress of authoring, reviewing, approving and submitting to publishing, including submissions across multiple countries and clinical studies.
Lead development of responses to health authority questions and documentation requests.
Ensure appropriate archiving of source technical documentation.
Lead review of chemistry, manufacturing, and controls‑related documentation (e.g., INDs, IMPDs, NDAs, BLAs) with SMEs, CDMOs and Exelixis leadership; may be required to provide relevant content or develop documents and templates as necessary.
Track and manage external partner regulatory actions, documenting regulatory actions in both post‑approval and development stage changes through completion.
Liaise internally with Regulatory Affairs CMC to coordinate CMC changes with other aspects of the development programs.
Ensure continued regulatory compliance and phase‑appropriate, risk‑based approaches to manufacturing flexibility while adhering to change‑control procedures and health authority requirements.
Monitor Biologics CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities.
Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
Work with cross‑functional teams to identify and support continuous improvement opportunities for processes and systems.
Provide strategic and forward‑looking guidance regarding processes and systems surrounding review committees.
People‑management responsibility and oversight (through direct reports and as an individual contributor as needed) within Bio CMC and cross‑functionally.
Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimisation and efficiency commensurate with departmental and company growth.
Lead internal preparation of CMC strategy in support of any required meetings with regulatory agencies and/or RFIs from health authorities, including preparation of supporting documentation, as necessary.
Liaise internally with members of Exelixis' functional departments.
Liaise externally with vendors, partners, and joint development collaborators.
SUPERVISORY RESPONSIBILITIES
Leads or manages the work of others by providing guidance to subordinates or teams.
EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS Education:
Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or
Master's degree in related discipline and a minimum of eleven years of related experience; or
PhD degree in related discipline and a minimum of eight years of related experience; or
Equivalent combination of education and experience.
Experience:
Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training.
Minimum ten years regulatory experience in a position of substantial responsibility.
Experience with Biologics and ADCs.
Prior experience working with Health Authorities and/or review divisions at FDA required.
Experience in oncology preferred.
Knowledge, Skills and Abilities:
Demonstrated knowledge of US and international regulatory requirements pertinent to this role.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Exercises problem solving, strategic thinking skills with ability to impact and influence.
Guides the successful completion of major programmes, projects and/or functions.
Interprets, executes, and recommends modifications to departmental and cross‑functional processes and standards.
Leads or manages the work of others by providing guidance to subordinates or teams based on organisational goals and company policy, with responsibility for results, including costs, methods, and staffing.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Environment: primarily working indoors.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Our office is a modern, open‑plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $191,500 - $272,000 annually. The base pay offered will take into account the candidate's geographic region, job‑related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or for field sales staff, a sales‑based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long‑term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company‑wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
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ESSENTIAL DUTIES/RESPONSIBILITIES
Lead development of high‑quality, phase‑appropriate CMC‑related submissions to regulatory authorities and regulatory affairs, tracking progress of authoring, reviewing, approving and submitting to publishing, including submissions across multiple countries and clinical studies.
Lead development of responses to health authority questions and documentation requests.
Ensure appropriate archiving of source technical documentation.
Lead review of chemistry, manufacturing, and controls‑related documentation (e.g., INDs, IMPDs, NDAs, BLAs) with SMEs, CDMOs and Exelixis leadership; may be required to provide relevant content or develop documents and templates as necessary.
Track and manage external partner regulatory actions, documenting regulatory actions in both post‑approval and development stage changes through completion.
Liaise internally with Regulatory Affairs CMC to coordinate CMC changes with other aspects of the development programs.
Ensure continued regulatory compliance and phase‑appropriate, risk‑based approaches to manufacturing flexibility while adhering to change‑control procedures and health authority requirements.
Monitor Biologics CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities.
Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
Work with cross‑functional teams to identify and support continuous improvement opportunities for processes and systems.
Provide strategic and forward‑looking guidance regarding processes and systems surrounding review committees.
People‑management responsibility and oversight (through direct reports and as an individual contributor as needed) within Bio CMC and cross‑functionally.
Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimisation and efficiency commensurate with departmental and company growth.
Lead internal preparation of CMC strategy in support of any required meetings with regulatory agencies and/or RFIs from health authorities, including preparation of supporting documentation, as necessary.
Liaise internally with members of Exelixis' functional departments.
Liaise externally with vendors, partners, and joint development collaborators.
SUPERVISORY RESPONSIBILITIES
Leads or manages the work of others by providing guidance to subordinates or teams.
EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS Education:
Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or
Master's degree in related discipline and a minimum of eleven years of related experience; or
PhD degree in related discipline and a minimum of eight years of related experience; or
Equivalent combination of education and experience.
Experience:
Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training.
Minimum ten years regulatory experience in a position of substantial responsibility.
Experience with Biologics and ADCs.
Prior experience working with Health Authorities and/or review divisions at FDA required.
Experience in oncology preferred.
Knowledge, Skills and Abilities:
Demonstrated knowledge of US and international regulatory requirements pertinent to this role.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Exercises problem solving, strategic thinking skills with ability to impact and influence.
Guides the successful completion of major programmes, projects and/or functions.
Interprets, executes, and recommends modifications to departmental and cross‑functional processes and standards.
Leads or manages the work of others by providing guidance to subordinates or teams based on organisational goals and company policy, with responsibility for results, including costs, methods, and staffing.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Environment: primarily working indoors.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Our office is a modern, open‑plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $191,500 - $272,000 annually. The base pay offered will take into account the candidate's geographic region, job‑related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or for field sales staff, a sales‑based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long‑term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company‑wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
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