Senior Document and Regulatory Affairs Specialist - REMOTE US
Battelle Memorial Institute
Type: Full Time
Preferred Education: 4 Year Degree
Salary: $100,000 - $135,000/yr DOE
Internal Number: 69963
Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
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 the FDA. Remote opportunity.
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 and submit 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. 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
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.
Contribute to the development and maintenance of company and departmental working practices and procedures.
Coaches and supports the development of regulatory team members.
THE FOLLOWING IS REQUIRED
Bachelor’s degree in a science, healthcare, pharmaceutical or regulatory discipline required; Graduate degree preferred.
5-7 years in pharmaceutical product development.
3+ years of experience in pharmaceutical regulatory affairs.
Strong written, verbal, and interpersonal skills; adept at in-person and remote communication.
Working knowledge of current 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. and must be a U.S. Citizen with ability to obtain Department of Defense (DoD) security clearance.
THE FOLLOWING IS DESIRED
Regulatory Affairs Certification preferred.
Experience with medical devices and/or combination products
A combination of education and experience may be considered for this role
Assume up to 10% travel to Battelle’s place(s) of business and/or to meetings with regulatory agencies may be required.
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.