Regulatory Affairs Manager

Role Summary

The Manager, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Executive Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required.

Responsibilities

• Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed.
• Act as a regulatory lead on a Phase 1, 2 or 3 clinical study
• Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization.
• Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications.
• Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, routine submissions, and amendments as needed.
• Develop and manage project timelines for regulatory submissions.
• Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions.
• Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages.
• Track submissions, correspondence, and commitments with health authorities.
• Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional.
• Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Conduct regulatory intelligence or research projects as required.

Qualifications

• Required: Bachelor‚Äôs or M.S./Ph.D. degree in scientific area.
• Required: Minimum of 7 years‚Äô experience with a Bachelor‚Äôs or 5 years‚Äô experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting.
• Required: Minimum of 2 years supervisory experience.
• Equivalent combination of relevant education and applicable job experience may be considered.
• Experience and understanding of ICH, GCP, and FDA regulations; experience with US IND and/or NDA submissions.
• Ability to work independently and within project teams; strong written and oral communication skills.
• Strong organizational and interpersonal skills; ability to meet deadlines in a fast-paced setting.
• Software: Windows, MS Office; advanced MS Word and Adobe PDF knowledge.

Skills

• Regulatory strategy development and global submissions
• Regulatory intelligence and research
• Project management and timeline development
• Cross-functional collaboration and vendor coordination
• Documentation review and quality assurance for regulatory submissions

Education

• Bachelor‚Äôs or MS/PhD in a scientific field

Additional Requirements

• Travel up to 5% may be required