Johnson & Johnson Careers
Director Regulatory Affairs, Regional Strategic Implementation Leader
Requisition ID: 00001D9W
Johnson & Johnson Pharmaceutical Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Regulatory Affairs, Regional Strategic Implementation Leader to be based in Raritan, NJ, Titusville, NJ, Spring House, PA, High Wycombe, UK, Beerse, Belgium, Leiden, Netherlands or Latin America.
This position provides regional (Latin America, Asia Pacific and EMEA – non EU) strategic execution oversight and support for one or more therapeutic areas. The position is responsible for working with the Regional Regulatory Leaders, local operating companies and global regulatory teams (GRTs) to implement/execute strategies for both products on the market and products under development to meet the goals of the compound development teams, global regulatory teams, regional teams and local operating companies.
- Regional Strategic Implementation drives and leverages cross-regional synergies and efficiencies.
- Is accountable for the development of regional strategic implementation plans. Understands regional and local requirements and advises the Global Regulatory Team (GRT), Compound Development Team (CDT) and regional teams on implementation issues pertaining to regional regulatory strategies.
- Participates as a member of the project related GRT; supports the GRT by providing oversight and support for the implementation of regional input into compound development, registration and life cycle management.
- Is accountable for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
- Understands how supply chain decisions impact registrations in the regions. Develops and updates contingency plans for the execution of regional regulatory strategies and refines regional plans as new data become available.
- Leads the Cross-regional Working group to ensure timely implementation of product objectives, and aligns regional deliverables with those of the global teams.
- Facilitates tactical implementation at the regional level, and ensures ongoing and effective communications with the regional and global teams on product activities and issues, related to strategic execution.
- Represents the regions and provides input on implications for regional & global regulatory strategy through participation in other product-related teams (e.g., submission teams, Labelling Working Groups, CTA Working Groups, query response teams, clinical teams, etc.), and provides team leadership where appropriate.
- Works with regional RA Intelligence providers (e.g. GRPI, Regional Regulatory Leaders, LOCs) to deliver knowledge management to the organization.
- Builds and maintains a strong knowledge management base (collection/sharing).
- Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline is required.
- Minimum of 10 years of overall experience is required, (8+ years relevant pharmaceutical industry experience, including at least 5 years of regulatory experience) OR Masters/PharmD and 8+ years; PhD and 6+ years.
- Breadth of global regulatory affairs experience in global drug development and commercialized products (for example, experience in multiple therapeutic areas, multiple phases of drug development) is required.
- Regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience is preferred.
- Experience specifically in AP, LA or EMEA non-EU countries is desirable.
- Good working knowledge of regulations and guidelines related to drug development and registration is required.
- Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable.
- Demonstrated leadership and contribution to drug development strategies and execution thereof.
- Demonstrated ability to handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to
- Experience working within a matrix environment is desirable.
- Previous experience managing both projects and people, and experience in working/leading project teams is required.
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Latin America, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)