Senior Manager, Global Regulatory Affairs
Location
United States
Posted
3 days ago
Salary
$132K - $176K / year
Job Description
Job Requirements
- Bachelor’s degree with minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong knowledge and understanding of global regulatory requirements, including interpretation of regulations, guidelines, and policy statements.
- Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).
- Excellent operational competencies, including planning, organization, and project management skills.
- Strong oral and written communication skills, with the ability to clearly convey regulatory concepts and updates to cross-functional teams.
- Proven ability to build collaborative relationships across functions and contribute to innovative problem-solving.
- Experience with regulatory systems and tools such as Veeva Vault, Docubridge, and CTIS.
- Ability to work independently and serve as a reliable team member in a fast-paced, matrixed environment.
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
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