Manager, Regulatory Affairs

Key Responsibilities

• Support the regulatory CMC functions in assigned project(s) to drive global regulatory timelines and milestones throughout the lifecycle of product development.
• Manage the preparation and filing of regulatory CMC submissions, commitments, and change amendments.
• Author and review regulatory CMC documents to ensure that all submissions are of high quality.
• Afford assistance in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc.
• Review CMC, clinical, and nonclinical documentation, including change controls, certificates of analyses, labels, study reports, clinical protocols, DSURs, Investigator Brochures, to ensure GxP and regulatory compliance.
• Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development and communicate changes in regulatory information to cross-functional teams.

Qualifications

• Experienced in FDA and/or ex-US submissions.
• Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
• Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred.
• At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry, with five years of Regulatory CMC experience.
• Previous experience in quality assurance, analytical testing, manufacturing, and research is Key Role-related.

Role-related Competencies

• Able to facilitate/impact and influence effective planning interactions and discussions.
• Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines.
• Able to acquire this knowledge in a short timeframe.

Core Competencies

• Knowledge of Statutory Framework and Guidance procedures followed by FDA/EMA.
• Understanding of product development.
• Strong verbal and written communication skills.
• Strong working knowledge of Microsoft Office and other PC-related applications.
• Must have strong working knowledge of Microsoft Office and other PC-related applications.
• Must take initiative and have ability to work independently and as a team member, offer assistance wherever needed.
• Excellent oral and written English communication skills.
• Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines.
• Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
• Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
• Problem solving, strategic thinking skills with ability to impact and influence.
• Attention to detail with accuracy and quality.
• Ability to understand and effectively relate to external and internal customers.
• Business awareness and professionalism.

Pay

$130,000—$179,000 USD

Schedule

To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.