Senior Document and Regulatory Affairs Specialist - REMOTE US
Battelle Memorial Institute
Type: Full Time
Required Education: 4 Year Degree
Salary: $100,000 - $135,000/yr DOE
RAC (Regulatory Affairs Certification)
Internal Number: 69963
Battelle is seeking a Senior Document and Regulatory Affairs Specialist (Program Manager) to provide regulatory support and strategy development for pharmaceuticals in early and late-stage development through licensure. This position will work closely with clients and internal departments to maintain compliance with regulatory requirements and prepare documents for submission to regulatory authorities and will also serve as the primary point of contact with regulatory agencies. Remote opportunity for East Coast or Midwest.
You will be taking introductory products through entire cycle including FDA approval!
Serve as the regulatory subject matter expert on project teams
Research and develop regulatory strategies, evaluate risk and plan for contingencies for proposed regulatory strategies, and recommend regulatory pathway(s) for investigational, new or modified products.
Incorporates and complies with all applicable laws and regulations.
Lead the preparation of submissions: work with project teams and partner organizations to define contributions to submissions, author and/or review submissions and other regulatory documents.
Serve as the primary liaison for FDA on assigned projects (US Agent). Interface and coordinate with the regulatory agencies (i.e. FDA) on submissions, approvals or other topics.
Coordinate regulatory agency meeting activities, including preparing meeting materials and meeting attendance.
Represent the company as a regulatory SME and assist with oversight of clinical development teams, manufacturing teams, etc. (internal or third-party). May include but is not limited to review and approval of product label and information, cGMP documents, clinical protocols, etc.
Maintain knowledge of the regulatory environment, regulations and guidance. Identify potential approval risks for ongoing projects based on changes to regulations and/or standards.
Oversee the development and maintenance of regulatory files and databases.
Contribute to the development and maintenance of company and departmental working practices and procedures.
Coaches and supports the development of regulatory team members.
Bachelor’s degree in a science, healthcare, pharmaceutical or regulatory discipline required; Graduate degree preferred.
7-10+ years in pharmaceutical product development.
Minimum 5 years of experience in pharmaceutical regulatory affairs.
Strong written, verbal, and interpersonal skills; adept at in-person and remote communication.
Current experience and working knowledge of FDA regulations
Ability to manage multiple projects while thinking critically and creatively to provide solution-focused strategy recommendations.
Demonstrated success in preparing and submitting applications to the FDA and/or other regulatory agencies.
This position may be remote, but applicants must be based in the U.S. (East coast or Midwest) and must be a U.S. Citizen with ability to obtain Department of Defense (DoD) security clearance.
Battelle is solving the world’s most pressing challenges.
We deliver when others can’t. We conduct research and development, manage laboratories, design and manufacture products, and deliver critical services for our clients – whether you are a multi-national corporation, a small start-up organization or a government agency.
We are valued for our independence and ability to innovate.
Battelle's vision is to be a major force in science and technology discovery and in the translation of knowledge into innovative applications that have significant societal and economic impacts.