Client's job description:
We are seeking a highly motivated individual for a Senior Manager/Associate Director/Director position to facilitate the coordination of European and US regulatory deliverables within our Regulatory Affairs team. This position is located at our Gaithersburg, MD facility and will report to the Senior Director or VP of Regulatory Affairs. This position will ensure coordination of global regulatory submission strategies, working in close collaboration with the US and EU-based cross-functional teams, to support regulatory filings through licensure and beyond.
· Bachelor's degree preferably in a scientific field; advanced degree desirable.
· A minimum of 8+ years in the biotechnology industry with at least 6 years in Regulatory Affairs.
· Demonstrated understanding of the drug development process, particularly with vaccines or biologics.
· Working knowledge of US, EU, and other regulations and industry standards pertaining to regulatory requirements for drug/vaccine development, including ICH CTD/eCTD structure and requirements.
· Ability to work independently and within a group setting and to interact effectively with different functional departments across the organization.
· Shows strong initiative and drive; must be an organized self-starter.
· Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
· Able and willing to work in a fast-paced environment while managing multiple priorities. Demonstrates flexible and attention to detail.
Responsibilities include but are not limited to:
· Coordinate with US and EU cross-functional teams (quality, nonclinical, and clinical) to identify, track, and gather required documentation and data needed to support global regulatory filings (eg, BLA and MAA) and responses to health authority queries.
· Develop strategies to most efficiently streamline use of regulatory documents to support multiple global regulatory filings; identify and track country-specific requirements and documents.
· Coordinate, track, and build database of all health authority queries and responses.
· Review and quality control (QC) of various regulatory documents to ensure suitability for global regulatory filings.
· Ensure that overall regulatory project timelines are aligned globally to facilitate the coordination and preparation of timely regulatory submissions in various regions.
· Perform directed research for regulatory aspects of new drug development.
· Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.