Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs (Fixed Term)

• Implementing of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
• Representing the regions and contributes to the regional & global regulatory strategy through participation in product-related teams such as, Global Regulatory Teams, submission teams, Labeling Working Groups, CTA Working Groups, response teams, clinical teams, etc., and provides team leadership where appropriate.
• Advising product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
• Leading the Regional Working groups to ensure timely execution of product objectives and aligns regional deliverables with those of the global teams.
• Facilitating tactical implementation at the regional level and ensures ongoing and effective communications with the regional and global teams on product activities and issues.
• Leveraging TA, strategic, tactical, operational, and procedural synergies and efficiencies across regions.
• Providing regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
• Liaising directly with Local operating companies as needed and apply the understanding of worldwide health authorities and applicability of procedures to the regions to help in the preparation for meetings with regulatory agencies in the regions.
• Overseeing management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
• Developing of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, development of tactical planning and timelines, including submission plans, review and preparation submission documents for the products’ life cycle, and communication to relevant groups.
• Preparing of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies.
• Manageing and tracking country-specific requirements for local submission purposes (e.g. legal and technical documents, RMP).
• Overseeing development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.
• Using Gen AI tools such as Copilot.

• Occasional travel - less than 10%

Eligible for severance.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.

Purpose: This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. This person is responsible for collaborating with the Global and Regional Regulatory Leaders, functional area experts and Local Operating Companies to implement/execute the company’s regulatory strategies for both marketed products and products under development in line with R&D, regional and local business objectives. This person will function in a matrix environment and must exhibit strong leadership skills. Responsibilities include: