Global Regulatory Leader for Oncology Projects integrates multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified global regulatory strategies. Leads Global Regulatory Team(s) - activities and responsibilities will include, but are not limited to;
- The facilitation and coordination of team meetings, representation of Global Regulatory Affairs and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally and to provide input on governance recommendations.
- Ensures regulatory strategies throughout lifecycle of compounds as appropriate. Refines regulatory strategies as new data become available and re-assess as necessary.
- Develops and updates contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile.
- Leads the preparation of regulatory dossiers for submission to Health Authorities.
- Leads Global Regulatory Team(s) to develop global marketing approval submission plans and timing, modifies submission plans and aligns with sourcing, Intellectual Property and launch strategies as appropriate.
- Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities.
- Works with the Global Regulatory Team to provide input for target labeling, and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy.
- As a member of the CDT, provides feedback to Discovery and other functions that may translate into potential new uses. Participates in and conducts licensing evaluations as needed.
- May manage a staff, including staff that supports additional portfolio products.
- Integrate multiple inputs from regional and functional GRT members to create and execute a coherent and unified global regulatory strategy for one or more product (s).
- Refine regulatory strategy as new data become available and re-assess as necessary.
- Lead, facilitate, and coordinate GRT meetings.
- Represent Regulatory viewpoint and expertise on the CDT, including regulatory risk/benefit evaluations associated with proposed strategies.
- Provide input into strategy for pricing and reimbursement.
- Accountable for regulatory recommendations for governance processes.
- Develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product.
- Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label.
- Develop strategy for providing responses to HA questions (ensure alignment with global strategy).
- Negotiate regional labeling with HAs (ensure alignment with global strategy) as appropriate.
- Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA / MAA / IRD/IND/CTA).
- Work with the clinical team to develop clinical trial submission plans.
- Work with the GRT to develop global marketing approval submission plan and timing.
- Conduct licensing evaluations (as needed).
- Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy.
- As a member of the clinical team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies.
- Provide feedback to Discovery and other functions that may translate into potential new compounds and uses.
- Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy.
- Provide feedback to Discovery and other functions that may translate into potential new compounds and uses.
Desired Skills and Experience
Qualifications
A minimum of Bachelor’s degree in a scientific discipline required. An advanced degree (MS, PhD, MD or Pharm D) is required.
Extensive pharmaceutical industry or health authority experience, and significant RA or related experience is required.
In-depth experience within a supervisory capacity or managing teams within matrix environment is required.
Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is required.
Working knowledge of WW HA laws, regulations, guidance and global regulation submission routes available for new study drugs is required.
Detailed understanding of competitors in the area and what they are doing in early/late development and knowledge of labeling aspects is required. Solid understanding of biology and chemistry relevant to the Oncology therapeutic area is required.
Experience developing regulatory strategies and an understanding of product development is required.
This position will be located in High Wycombe, UK or Raritan, NJ and will require 10-20% travel, both International and Domestic.
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