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Job description
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
Not Applicable
Employment type
Full-time
Job function
Science
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.