The position is responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for InGeneron’s platform device which produces a cell therapy, from product-development related strategy and file construction through product approval, including regulatory submissions.
- Develop and execute regulatory strategies for earliest possible approvals for development programs.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Prepare submissions and regulatory filings of IDEs, PMAs, technical files and design dossiers to the MDD and MDR, change notices for manufacturing changes, and other submission documents including meeting packages, briefing documents, responses, supplements etc.
- Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; and authorize investigational product shipment to clinical sites.
- Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
- Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable. Review and approve labeling.
- Aid in construction of technical files and other regulatory submission documents.
- Interface with international affiliates on regional regulatory strategy and implementation plans.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
- Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.
- Benefits offered
- 401K, Dental, Life, Medical, Vision
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Ability to communicate and interact effectively across departments and on the project team(s).
- Results driven and team-orientated, with the ability to influence outcomes.
- Bachelor’s or Master’s degree in a scientific discipline required.
- 7+ years’ experience in Regulatory Affairs in pharmaceutical, biotechnology or device industry.
- Experience working with CBER a plus.
- Thorough knowledge of the drug, device and combination product development process with demonstrated experience in preparing global regulatory submissions.
- Experience in regulatory affairs (device / pharmaceutical / biotech industry): 10 years (Required)
- Experience in US and EU product approvals (Required)
Please e-mail your resume to firstname.lastname@example.org or contact us at any time if you have questions.