Work Location
Corporate Headquarters (South San Francisco, CA) – Hybrid
Position Summary
This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative 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 regulatory agencies to support development and registration strategies. The Executive Director/Senior Director, 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.Salary range: Sr. Director - 269,700 - 308,900
Responsibilities
- Provides regulatory leadership 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 develop, coordinate and implement the regulatory strategies and submissions for global CTAs for new and ongoing clinical studies.
- Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management and Health Authority interactions. Represents Regulatory on Program Core Teams as applicable.
- Liaise with FDA, EMA and other Regulatory Agencies, as needed.
- Oversee the preparation and submission of assigned sections of filings to regulatory authorities, including, but not limited to, IND, NDA, CTA, MAA applications.
- Lead and manage FDA/EMA meetings, including leading briefing documents and meeting minutes.
- 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 day to day reports, submissions, requests for Annexon products
- Other duties as required.
Qualifications
- PhD/PharmD with 12+ years’ experience in Regulatory Affairs or BS/MS/MSN with 14+ years’ experience.
- Experience in a successful leadership role in managing, developing late-stage clinical candidate drugs.
- Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD
- 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. Experience with division of ophthalmology is a plus
- 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.
- S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
- 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.
What Annexon offers
- Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with 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, as well as other benefits.
Company Summary
Annexon Biosciences (Nasdaq: ANNX) is 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. Annexon’s 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, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.Staffing AgenciesAnnexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences.
Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.
