Associate Director, Regulatory Affairs, Europe Regulatory Policy – Intelligence

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Report directly to the Head of Europe, Regulatory Policy & Intelligence.

• Oversee and direct regional topics within the regulatory policy and intelligence domain.

• Establish scientific and regulatory policy initiatives pertinent to designated areas.

• Act as a policy subject matter expert, leveraging extensive knowledge of critical regulatory challenges and scientific foundations.

• Evaluate proposed policies and articulate the implications of emerging trends.

• Spearhead the development of corporate stances for dissemination to trade associations, ensuring alignment across functions.

• Prepare and deliver intricate written and oral reports to senior management and external stakeholders.

• Employ negotiation skills to navigate policy challenges and convey the repercussions of selected alternatives.

• Serve as a liaison to trade associations regarding scientific and regulatory matters.

• Assist supervisors and senior management in discussions surrounding intricate policy issues at trade associations.

• Contribute to the regulatory product development strategy by addressing information inquiries and assessing the regulatory landscape.

• Engage in external outreach with regulators, peers, and trade associations.

• Attend policy-related meetings to strengthen AbbVie’s relationships.

• Leverage local networks of pharmaceutical companies to gather policy-related information.

• Collaborate with regulatory affairs and cross-functional colleagues to ensure policies align with AbbVie’s portfolio priorities.

• Lead the development of responses from cross-functional, multidisciplinary teams to health authority consultations.

• Provide intelligence insights that support compliance with scientific, ethical, statutory, quality, and business requirements.

⛳️ Requirements

• Degrees in Pharmacy, Chemistry, Biology, or a relevant Master’s degree or PhD in a scientific, health, legal, or business discipline is preferred.

• Demonstrated experience within the pharmaceutical industry or with a health authority.

• Background in regulatory policy and intelligence, including experience with trade associations, gained either in the pharmaceutical sector or at a health authority.

• Strong understanding of healthcare regulations that support drug development, including experience in regulatory interpretation.

• Experience operating in a complex, matrixed environment.

• Proven capability to assimilate policy trends and suggest policy solutions, with the ability to influence both internally and externally.

• Outstanding communication skills to convert complex data into valuable insights.

• Well-established regulatory connections across European countries.

• Experience with both pharmaceuticals and medical devices would be advantageous.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Commitment to integrity, innovation, transformation of lives, and community service.