Senior Regulatory Affairs Manager- REMOTE
I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission planning, coordination, and execution across multiple regions, ensuring smooth and successful interactions with health and regulatory authorities.
Responsibilities
- Lead preparation and submission, and maintenance of CTAs to regulatory/health authorities
- Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance
- Lead in the preparation, submission, and maintenance of CTAs to regulatory authorities
- Lead the preparation and execution of health authorities meetings and questions (FDA, EMA, PMDA, etc.)
- Keep track of submissions and approval status globally, providing regular updates and reports to leadership
Requirements
- At least 8 years in regulatory affairs within the life science space
- Bachelor's degree in life sciences or relevant field
- Strong knowledge of regulatory guidelines and clinical trial regulations
- Proven experience with global CTAs submissions and IND maintenance
- Ability to manage multiple priorities and work in a fast-paced, dynamic environment
This role comes with a competitive base salary and benefits.
- Medical insurance
- Pension plan
- Child care support
- Vision insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Student loan assistance
Seniority level
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