Regulatory Affairs Manager — FDA Submissions & Strategy

Viatris; Washington (District of Columbia); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Viatris is seeking a Manager, Regulatory Affairs in Washington, DC to lead regulatory submissions and compliance across IND, NDA, and ANDA programs. The role requires coordinating with QA, QC, Manufacturing, R&D and other teams to ensure timely documentation and approvals.

The candidate must have a bachelor’s degree with 4–7 years of regulatory experience and be fluent in English, with the ability to craft detailed reports and communicate across departments.

Qualifications

• Bachelor's degree (or equivalent) with 4–7 years in regulatory affairs.
• Proficient in spoken and written English; able to write comprehensive reports.
• Willing to work 2–3 days per week in the Washington, DC office.

Responsibilities

• Review and approve submissions such as IND, NDA, ANDA per FDA requirements.
• Review and provide feedback on technical documentation for annual reports and amendments.
• Recommend regulatory reporting mechanisms under FDA regulations and Health Authorities.
• Provide regulatory review of technical documentation, product reports, and batch records for FDA submission.
• Guide other departments on regulatory changes and ensure commitments to FDA are met.
• Prepare, review and finalize amendments and supplements to product applications.
• Maintain knowledge of FDA regulations and guidance related to changes to approved regulatory applications.

Skills

Regulatory affairs

English fluency

Technical documentation

Cross-functional collaboration

Education

Bachelor's degree

Job description

Viatris is seeking a Manager, Regulatory Affairs in Washington, DC to lead regulatory submissions and compliance across IND, NDA, and ANDA programs. The role requires coordinating with QA, QC, Manufacturing, R&D and other teams to ensure timely documentation and approvals.

The candidate must have a bachelor’s degree with 4–7 years of regulatory experience and be fluent in English, with the ability to craft detailed reports and communicate across departments.