International Regulatory Affairs Director

The International Regulatory Affairs Director (IRAD)is responsible fordeveloping and implementing the international regulatory strategy for a group of products. This role ensures that the strategy is designed to achieve rapid approval withadvantageouslabeling, aligning with the product properties and the needsidentifiedby the business, markets, and patients. The IRAD possesses strategic leadership skills, understands regional regulatory science, and has extensive knowledge of drug/biologic development processes and strategies.

Understanding of the disease area is crucial for crafting cross-functional discussions with regional and/or Global Product Teams (GPT) and relevant team members. Familiarity with regulatory systems across international markets and a thorough understanding of commercial factors are critical to success in this role.

Accountabilities

Project Regulatory Strategy
- Develop and implement innovative international regulatory strategies for a product/group of products, ensuring rapid approval withadvantageouslabeling.
- Lead the development, communication, and updates of theInternationalsection of the Regulatory Strategy Document (RSD) for assigned products/projects.
- Ensureappropriate cross-functionalcoordination, particularly with International Commercial, peer review, and senior team member endorsement from ILT and GPT.
-Attainregulatory breakthroughs, including evaluating the likelihood of regulatory success and implementing risk mitigation measures.
- Objectively assess emerging data against aspirations and update senior management on project risks/mitigation activities.

Leadership
- Serve as the single point of contact and Regional Regulatory Affairs representative on Regional Product Teams.
- Lead the planning and construction of theInternationaldossier.
- Develop and implementan optimalregional (International) regulatory strategy for a product/group of products, ensuring rapid market access withadvantageouslabeling.
- Ensure effective regulatory representation at all health authority meetings and clear documentation of discussions and agreements.
- Lead regulatory staff working on a product/project to ensure prioritizedobjectivesare delivered on time and with quality.
-Participatein skill development, coaching, and performance feedback of other regulatory staff.
- Provide regulatory leadership in product in-license/due diligence review, product divestment, and product withdrawal.
- Contribute proactively across RAD community and/or Regulatory Excellenceobjectivesand activities.

Regulatory Environment
- Partner with marketing company staff tomonitorchanges in the regulatory environment and support regional and/or Global Product Teams (GPT) or ILT accordingly.
- Influence developing views/guidance within leading Health Authorities on specific topics relevant to their project or regulatory more generally.

Essential Skills/Experience
- Bachelor’s degree in a science-related field or equivalent experience.
-Previousexperience in attending and/or helping a team prepare for Major Health Authority interactions.
- Extensive experience or equivalent in regulatory drug development, including product approval/launch.
- Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business-critical, and high-profile development program.
- Successful leadership of major regulatory approval in the International Region.
- Strong cross-cultural awareness and ability to work independently with Commercial and Marketing Company colleagues from across the globe.
- Mustdemonstrateproficienciesin critical thinking, critical influencing, innovation, initiative, leadership, and excellent oral and written communication skills.

• Must have prior experience in creating and implementingaccelerated regulatorystrategiesfor major MAA / CLE in Internationalmarkets.

• Must have in depth knowledge and experience in the required Therapeutic Areateam,either  Oncology, orCVRM,R&I, Vaccines. 

Desirable Skills/Experience
- Strong commercial awareness.
- Subject Matter Expert in International strategy and tactical delivery.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challengeperceptions.That'swhy we work, on average, a minimum of three days per week from the office. But thatdoesn'tmeanwe'renot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.