Senior Director, Regulatory Policy Leader EMEA & CMC

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

We are searching for the best talent for Senior Director, Regulatory Policy Leader EMEA & CMC.

Purpose: The Senior Director, Regulatory Policy Leader EMEA & CMC leads regional policy staff advancing regulatory policy priorities for J&J. The leader is an integral member of GRPI leadership, providing regional regulatory policy subject matter expertise to drive advocacy and deliver results. The EMEA lead uses a deep understanding of the regional regulatory framework to develop science-based positions and advocacy plans, and manage a high performing team. They also lead CMC regulatory policy issues globally for GRPI and GRA.

The EMEA Leader represents J&J in interactions with health authorities on priority issues, actively engaging key decision makers. They partner with project teams, Government Affairs, Legal, and other stakeholders to advance priorities. Externally, the Senior Director leads effective interactions with EMEA trade associations, health authorities, and other organizations. Internally, the leader drives strategic advocacy, leverages expertise to help J&J navigate the regulatory environment, and creates opportunities to advance policies that support J&J R&D.

We are searching for the best talent for Senior Director, Regulatory Policy Leader EMEA & CMC.

Purpose: The Senior Director, Regulatory Policy Leader EMEA & CMC leads regional policy staff advancing regulatory policy priorities for J&J. The leader is an integral member of GRPI leadership, providing regional regulatory policy subject matter expertise to drive advocacy and deliver results. The EMEA lead uses a deep understanding of the regional regulatory framework to develop science-based positions and advocacy plans, and manage a high performing team. They also lead CMC regulatory policy issues globally for GRPI and GRA.

The EMEA Leader represents J&J in interactions with health authorities on priority issues, actively engaging key decision makers. They partner with project teams, Government Affairs, Legal, and other stakeholders to advance priorities. Externally, the Senior Director leads effective interactions with EMEA trade associations, health authorities, and other organizations. Internally, the leader drives strategic advocacy, leverages expertise to help J&J navigate the regulatory environment, and creates opportunities to advance policies that support J&J R&D.

You will be responsible for:

• Directing a regional team to develop and implement advanced regulatory advocacy to achieve J&J objectives.

• Developing high quality and globally aligned regulatory policy strategies to support R&D priorities, partnering with key internal stakeholders.

• Providing leadership to drive effective advocacy through engagement with key regional trade associations and other organizations.

• Providing expert advice on key regulatory policy issues affecting the global and regional environment.

• Representing J&J in interactions with health authorities and government entities on regulatory advocacy issues, fostering relationships with key decisions makers.

• Managing regional process to provide effective comments on regulatory and legislative documents to help shape key regulatory policies.

• Leading CMC regulatory policy for GRPI and GRA.

Leadership

• Manage and coach team members and contribute to their individual development within GRPI.

• Lead activities of the regional group, leveraging expertise to ensure success meeting GRPI goals and objectives.

• Represent EMEA region in GRPI leadership team, helping to drive successful policy advocacy supporting GRA and R&D.

• Ensure clear and effective communication across GRPI, and alignment of regional and global strategic approaches.

• Represent GRPI on EMEA Leadership teams.

Qualifications / Requirements:

• Bachelor's/University or equivalent degree; advanced degree or focused degree in Law, Pharmacy, Medicine, Science or related discipline is required.

• 8-10 years experience in regulatory policy activities, within the EMEA region, national health authority, industry, or trade associations.

• Experience with CMC regulatory policy.

• Extensive people leadership and team development experience.

• Excellent working knowledge of the regional regulatory framework and application to pharmaceutical and product development.

• Highly developed network amongst regional regulators and other key associations and organizations.

• Knowledge of regulatory and legal texts; extensive regulatory affairs experience.

• Demonstrable success in developing and driving advocacy strategies.

• Strong analytical, problem-solving, and critical thinking skills.

• Excellent interpersonal and negotiating skills, with the track record of influence and collaboration to reach a desired result.

• Strong communication to create clear and concise messaging to leadership.

• Detail and solution oriented with ability to work within broad guidelines but challenge status quo.

Preferred:

• Experience working in the European Medicines Agency or a National Competent Authority in Europe.

• Experience working in FDA, or another regulatory agency on CMC regulatory policy issues.