Senior Manager Regulatory Affairs – Remote , East Coast

Biotechnology Company; New York (NY); Remote; USD 136,000 - 160,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Manager of Regulatory Affairs to support regulatory strategy for investigational products. This remote position requires expertise in compliance with FDA regulations, experience in filing INDs and NDAs, and strong project management skills. The role involves collaboration across teams and preparation for health authority interactions.

Benefits

20% bonus

Stock grant

Full benefits

Qualifications

• 4-5+ years of Regulatory Affairs experience in biotech/pharmaceutical industry.
• Experience filing INDs, NDAs in CTD/eCTD formats.
• Knowledge of US FDA and international pharmaceutical regulations.

Responsibilities

• Develop and implement regulatory strategies aligned with program goals.
• Lead preparation, review, and submission of regulatory documents.
• Collaborate with clinical, nonclinical, CMC, and PV teams.

Skills

Project Management

Negotiation

Collaboration

Regulatory Compliance

Time Management

Education

Bachelor’s degree in Life Sciences or related field

Tools

DocCompliance

MedXview

Job description

Senior Manager Regulatory Affairs – Remote, East Coast

New York, United States

Summary:

We have a biotech client in the NY/NJ area seeking a Senior Manager of Regulatory Affairs to support regulatory strategy and operations for investigational products in clinical stages. Responsibilities include ensuring compliance with 21 CFR Part 11, supporting US and ex-US regulatory submissions such as INDs, and engaging with health authorities.

Responsibilities:

1. Develop and implement regulatory strategies aligned with program goals.
2. Lead or support preparation, review, and submission of regulatory documents (IND, amendments, EU CTR submissions, etc.).
3. Represent Regulatory Affairs in program and study team meetings.
4. Collaborate with clinical, nonclinical, CMC, and PV teams to ensure compliance with global regulations.
5. Prepare for health authority interactions, including FDA and EMA submissions.
6. Manage timelines and quality of regulatory submissions.
7. Develop and review regulatory documents for FDA submissions.
8. Manage responses to information requests from health authorities.
9. Monitor and interpret US and global regulations to ensure compliance and best practices.
10. Improve regulatory document development and submission processes.

Requirements:

• Bachelor’s degree or equivalent in Life Sciences or related field.
• 4-5+ years of Regulatory Affairs experience in biotech/pharmaceutical industry.
• Experience filing INDs, NDAs in CTD/eCTD formats.
• Proven success in filing INDs, NDAs, MAAs, ANDAs, BLA’s.
• Knowledge of US FDA and international pharmaceutical regulations.
• Experience with global regulatory requirements, especially US, EU, ICH.
• Experience with document management software like DocCompliance or MedXview is preferred.
• Strong project management, negotiation, and collaboration skills.
• Ability to identify and resolve compliance risks.
• Experience working in cross-functional teams and fast-paced environments.
• Excellent time management, planning, organizational, and interpersonal skills.

Remote position with occasional visits to the NY/NJ office. Compensation up to $160k base, plus 20% bonus, stock grant, and full benefits.