Sr. Director / Director of Regulatory Affairs

Sr. Director Regulatory Affairs

This is a remote position.

The company is working on a drug / device combination product, they have a lot of expertise on the medical device side, the need the pharmaceutical expertise.

This is a new position, the Director has no reports at this time, this person will be able to build their own team over time. The individual will mostly be dealing with the CBER branch of the FDA and will be reporting to the CEO or CMO. The challenge they have had in filling this role is finding a candidate who is "hands on", strategic and can be a leader with a positive attitude. Someone who can zoom in and zoom out.

Strong pharmaceutical experience is a must. Candidates must be very strong in biologics, very experienced interactions with the FDA and the EU is a must, followed by some experience with China and Japan would be very helpful. Company would like someone on-site but very open to Remote-Option for the right candidate. The job title is Sr. Director Regulatory Affairs or Director of Regulatory Affairs they are not hung up on title, will look at strong RA Manager candidates. Need individual who has led projects at least 2 BLA's and involved with 5 or 6 IND's US Citizens and Green Card Holders.

The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects.

Requirements :

• 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.
• Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
• Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc.
• Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations
• Review clinical trial documents including clinical protocols / reports, investigator brochures, nonclinical reports, protocols / test methods; review and approve clinical manufacturing plans and labeling and authorize drug 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.
• Interface with international affiliates on regional regulatory strategy and implementation of plans.
• Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
• Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Education and / or job experience :