Position title: Director, GRA Regulatory Operations
Reporting to: SVP, Global Regulatory Affairs
Direct Reports: TBD
Key Objectives: To develop, manage and plan Regulatory strategy, operations and submissions. Coordinate and execute on project specific Regulatory milestone plans and submissions aligned with Corporate and Group’s strategic goals. Provide Regulatory insight, clear direction, regulatory risk/mitigation guidance and operational regulatory expertise. Represent the company at Regulatory authority meetings, due diligence and external vendor interactions. Serve as project lead and point of contact to advance the company drug candidates globally.
Key Accountabilities:
1. Develops regulatory strategy and operations capability to manage global submissions. Evaluates options to expedite FDA review and approval of drug submissions in conjunction with VP, Global Regulatory Affairs.
2. Leads regulatory operations functions, interacts with cross-functional SMEs to manage pre and post approval Health authority submissions. Coordinates and directs internal and external resources in preparation of and timely interactions to the FDA and other health authorities in support of development programs and products.
3. Leads regulatory project strategies and partners with global colleagues to manage regulatory activities in preparation of submissions and translates regulatory milestones into actionable plans and documents
4. As Regulatory operations SME, plan, write, review and publish Health Authority document submissions (e.g. NDA, DMF or Briefing Documents).
5. Demonstrates desire for personal and professional growth and to assume leadership of a Regulatory functional component such as CMC, Operations, OPDP, label and Reg intelligence
6. Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
7. Support relationships with regulatory and legislative agencies, globally addressing the scientific aspects of the company’s product portfolio.
Education and Experience:
− Experience: Candidates should have a minimum of 7-10 years of experience in pharmaceutical drug development, operations, project management, quality/regulatory lead, ideally with US and EU filings (IND’s BLA, NDA, DMF, MAA. ODD) preferably with biologics or radiopharmaceutical background
− Knowledge of US drug development regulations and guidelines; experience leading interactions with regulatory authorities, SA
− Well-developed leadership skills, including demonstrated cross-functional communication, collaboration, interpersonal and ability to influence and challenge regulatory thinking
− BS in scientific area. Pharm. D., Advanced degree preferred.
Personal Attributes:
− Commitment to the vision, mission and values of the company.
− Ability to work under timeline pressure
− Ability to prioritise competitive priorities/ objectives
− Ability and willingness to work collaboratively with global team members across multiple timezones
− Ability to provide candid feedback to management and external parties
Authorities:
− Financial: In line with Delegations of Authority Policy of the Board
− Other: N/A
Position title: Director, GRA Regulatory Operations
Reporting to: SVP, Global Regulatory Affairs
Direct Reports: TBD
Key Objectives: To develop, manage and plan Regulatory strategy, operations and submissions. Coordinate and execute on project specific Regulatory milestone plans and submissions aligned with Corporate and Group’s strategic goals. Provide Regulatory insight, clear direction, regulatory risk/mitigation guidance and operational regulatory expertise. Represent the company at Regulatory authority meetings, due diligence and external vendor interactions. Serve as project lead and point of contact to advance the company drug candidates globally.
Key Accountabilities:
1. Develops regulatory strategy and operations capability to manage global submissions. Evaluates options to expedite FDA review and approval of drug submissions in conjunction with VP, Global Regulatory Affairs.
2. Leads regulatory operations functions, interacts with cross-functional SMEs to manage pre and post approval Health authority submissions. Coordinates and directs internal and external resources in preparation of and timely interactions to the FDA and other health authorities in support of development programs and products.
3. Leads regulatory project strategies and partners with global colleagues to manage regulatory activities in preparation of submissions and translates regulatory milestones into actionable plans and documents
4. As Regulatory operations SME, plan, write, review and publish Health Authority document submissions (e.g. NDA, DMF or Briefing Documents).
5. Demonstrates desire for personal and professional growth and to assume leadership of a Regulatory functional component such as CMC, Operations, OPDP, label and Reg intelligence
6. Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
7. Support relationships with regulatory and legislative agencies, globally addressing the scientific aspects of the company’s product portfolio.
Education and Experience:
− Experience: Candidates should have a minimum of 7-10 years of experience in pharmaceutical drug development, operations, project management, quality/regulatory lead, ideally with US and EU filings (IND’s BLA, NDA, DMF, MAA. ODD) preferably with biologics or radiopharmaceutical background
− Knowledge of US drug development regulations and guidelines; experience leading interactions with regulatory authorities, SA
− Well-developed leadership skills, including demonstrated cross-functional communication, collaboration, interpersonal and ability to influence and challenge regulatory thinking
− BS in scientific area. Pharm. D., Advanced degree preferred.
Personal Attributes:
− Commitment to the vision, mission and values of the company.
− Ability to work under timeline pressure
− Ability to prioritise competitive priorities/ objectives
− Ability and willingness to work collaboratively with global team members across multiple timezones
− Ability to provide candid feedback to management and external parties
Authorities:
− Financial: In line with Delegations of Authority Policy of the Board
− Other: N/A