Job Title: Regulatory Affairs Strategist Position Description
- Leads regulatory activities for assigned products, including development of product regulatory strategy; advises product team on development activities; leads development and/or review of submission documentation; addresses Health Authority (HA) requests and drives HA responses.
- Participates in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.
- Regulatory Strategy Development: Provides regulatory interpretation, position and strategy for parenteral and/or combination product development from initial planning stages into life cycle management; identifies, monitors and resolves regulatory issues and reports progress to regulatory management.
- Regulatory Documentation: Develops and/or reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Supports development of labeling for assigned products. Advises cross-functional partners on key documents (e.g., clinical protocols, design history files, summaries, etc) required for regulatory submissions.
- Regulatory Submissions (IND/NDA): Plans and monitors regulatory submission activities; partners with project teams to assess regulatory support needs and aligns resources to provide regulatory support for submission activities. (EU CTA and MAA experience a plus).
- Interfacing with Authorities: Acts as the point of contact with regulatory authorities for assigned product(s), as needed.
- Compliance: Ensures compliance with all applicable laws / regulations. Demonstrates high ethical behavior in dealing with colleagues, regulators or other partners
- Requires BS in Life Sciences or relevant field an advance degree is preferred, with 5+ year regulatory experience.
- Experience in new drug regulated product strategy and submissions; ideal candidate will have a combination of regulatory and pharmaceutical experience.
- Professional experience should include parenterals and/or combination products.Experience developing regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience in development and preparation of successful regulatory submissions (INDs, NDAs, annual reports, labeling, etc). Strong technical writing and oral communication skills are a must.
- Working knowledge of relevant drug laws, regulations and guidance's/guidelines.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.