Biogen · 1 week ago
Associate Director, Global Regulatory Lead- West Coast Hub
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$144K/yr - $206K/yr
6+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation in developing life-changing medicines. The Associate Director, Regulatory Affairs will lead the development and execution of global regulatory strategies for product development and approval, managing relationships with regulatory authorities and providing support across various teams.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
BA/BS/University degree, Life/Health Sciences preferred
8 years pharmaceutical/biotechnology industry experience with technical management experience
Minimum of 6 years of experience in Regulatory Affairs
Comprehensive knowledge of applicable regulations
Experience in interpretation of regulations, guidelines, policy statements, etc
Expertise 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)
Demonstrated excellent leadership and communication skills, inclusive of supervisory/mentoring experience, and ability to lead project teams
Strong organizational skills, including the ability to prioritize personal workload
Excellent interpersonal skills and the ability to communicate effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
Preferred
Graduate degree
Some international regulatory experience preferred
Experience with biologics preferred
Expert knowledge and experience in gene therapy highly desirable
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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