Director - Global Regulatory - Johnson & Johnson - High Wycombe

Job description
The Director, Global Regulatory Leader supporting Ebola development programmes
Represents Global Regulatory Affairs and provides regulatory expertise to the Product Development Team and Clinical Team to facilitate successful marketed product development support globally and to provide input on governance recommendations.
Represent Regulatory viewpoint and expertise on the Product Development Team, including regulatory risk/benefit evaluations associated with proposed strategies; Provide input into strategy for pricing and reimbursement and/or access strategies

As a member of the Product Development Team, provides feedback to Discovery and other functions that may translate into potential new uses. Participates in and conducts licensing evaluations as needed.
As a member of the Clinical Team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies
Review pertinent product/project-related communications, manuscripts and publications
Leads, facilitates and coordinates 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.
Integrates multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified global regulatory strategies.
Ensures regulatory strategies throughout lifecycle of products 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/access strategy, and the Target Product Profile.
Leads the preparation of regulatory dossiers for submission to Health Authorities/notified bodies. Responsibilities include: preparation, editing and critical review of both investigational and marketing applications; correspondence and direct interaction with Health Authorities. Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities, develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product
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 a Labeling strategy. Follows-up on regional/local labeling strategies and supporting documentation for labeling. Coordinates and follows-up on variations and label update submissions to keep product compliance
Tracks information on submissions and approvals in collaboration with regional RLs and CMC group (if appropriate)
Evaluates the global regulatory landscape to proactively interpret and shape J&J policies and provide J&J comments on Health Authority guidance’s to support faster access to J&J innovative products. Shaping the external environment.
May manage a staff, including staff that supports additional portfolio products. Responsibilities include training on regulatory requirements and leadership on external influencing and commenting on new regulations, development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements.

Qualifications

Minimum of Bachelor degree in a scientific discipline required; Advanced degree (MS, PhD, MD or Pharm D) strongly preferred;
Minimum of 10 years pharmaceutical, d/or medical devices industry or health authority experience including at least 6 years of Regulatory Affairs experience required; Minimum of 4 years of experience within a supervisory capacity or managing teams within matrix environment required;
Wide range of experience in Regulatory Affairs (prior vaccines experience preferred) 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 products is required;
Be passionate, drive innovation, cultivate strong partnerships in- and externally
International experience developing regulatory strategies and an understanding of product development required; Experience managing a portfolio of multiple products required;
Experience in the Medical Device Industry is an advantage
Solid understanding of biology and chemistry relevant to therapeutic area is preferred; Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects required;
This position will require approximately 10-20% travel, both International and Domestic

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