Associate Director, Regulatory Affairs

Biogen•San Francisco, CA

About The Position

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports. What You’ll Do • Responsible for developing and executing global regulatory strategies for assigned projects and programs. • Support development of the preclinical and clinical development plan. • Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies. • Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages. • Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA. • Mentor Regulatory Managers. • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. • Provide input to Senior Management teams. • Maintain a global view as part of the whole regulatory team.

Requirements

BA/BS/University degree, Life/Health Sciences preferred.
8 years pharmaceutical/biotechnology industry experience with technical management experience.
Minimum of 6 years in RA.
Comprehensive knowledge of applicable regulations.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
Knowledge of regulations governing the development of drugs.
Solid knowledge of GCPs and GLPs.
Direct experience in interfacing with relevant regulatory authorities (FDA).
Foster effective, positive interactions with regulatory agencies, and corporate partners.
Ability to lead and influence project teams, committees, etc. to attain group goals.
Demonstrate excellent leadership and communication skills.
Ability to represent the department in project teams, committees and external meetings.
Demonstrate strong organizational skills, including the ability to prioritize personal workload.
Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.
Well organized, detail oriented, effective written and oral communication skills.
Supervisory/mentoring experience.
Ability to guide, train, supervise and prioritize workload of direct reports if applicable.
Expert knowledge and experience in gene therapy highly desirable.

Nice To Haves

Graduate degree.
Some international regulatory experience preferred.
Experience with biologics preferred.

Responsibilities

Responsible for developing and executing global regulatory strategies for assigned projects and programs.
Support development of the preclinical and clinical development plan.
Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies.
Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages.
Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA.
Mentor Regulatory Managers.
Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
Provide input to Senior Management teams.
Maintain a global view as part of the whole regulatory team.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation