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

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

• 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.
• Managing 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.

Experience and Skills

Education: Bachelor's degree with 8 years relevant experience (5 years pharm regulatory), Masters/PharmD with 6 years relevant experience (4 years pharm regulatory), or PhD with 4 years relevant experience (3 years pharm regulatory) required.

Required

• Breadth of global regulatory affairs experience in global drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development) is required.
• Demonstrated ability to independently handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required.
• Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones.
• Excellent English verbal and written Communication Skills.
• Experience in working/leading project teams; demonstrated project management skills is required.

Preferred

• Pharma Regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience.
• Experience specifically in AP, LA, EMEA countries is desirable.
• Good working knowledge of regulations and guidelines related to drug development and registration; Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable.
• Demonstrated contribution to drug development projects and implementation of strategies is desirable.

Other: Occasional travel - less than 10%. Eligible for severance.