Working in a team environment, you will be responsible for planning and coordinating regulatory submissions necessary to support clinical trials and product registration. This position will represent the company with domestic and international regulatory authorities and provide regulatory support for various departments, projects, and teams/committees.

Responsibilities:

• Create and execute regulatory development plans and manage timelines to achieve the stated goals.
• Interface directly with governmental personnel, including scientific reviewers, administrative support and management to facilitate the review and approval of regulatory applications.
• Work closely within the department and across the project team to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner.
• Coordinate the preparation and submission of required documents to regulatory agencies. Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements.
• Make certain that appropriate documentation is maintained to record regulatory decisions for the projects.

Qualifications:

• Bachelor’s degree required, preferably in life / health sciences field.
• 5+ years experience in regulatory affairs providing regulatory guidance in the development and/or post-marketing support of drugs or biologics including advertising and promotional labeling.
• Working knowledge of FDA organization, regulations and guidance documents. Knowledge of regulations pertaining to global regulatory agencies.
• Experience and knowledge in preparation of INDs, NDAs, BLAs, and supportive amendments of supplements.
• Knowledge of GMPs and biotechnology-derived product regulations as well an understanding of the pharmaceutical product life cycle.
• Demonstrated ability to work independently and manage multiple projects within cross-functional teams.