International regulatory legal counsel providing support for the Pharmaceutical Division of a top healthcare company
The company’s European Law Department is headquartered in Brussels (approximately 20 lawyers) and includes some 30 additional lawyers on decentralised locations in Europe and the Middle East.
Descriptif du poste
- Provide regulatory legal advice and support to a variety of functional groups in the EU pharmaceutical business of Johnson & Johnson, such as regulatory affairs including regulatory policy, medical and clinical affairs, healthcare compliance, quality and safety groups, government affairs and medical education. The position includes close and active partnership with therapeutic area business teams, as part of a multicultural and multi-disciplinary team.
- Provide regulatory legal advice on pharmacovilgance related matters and work closely together with the central safety group and internal and external business partners.
- As part of a multifunctional team, provide regulatory legal advice and support to international pharma projects and other commercial arrangements in a number of different therapeutic areas.
- As part of a multifunctional team, provide regulatory legal advice and support to the business development team on international agreements (such as licenses, acquisitions, disposals, collaborations).
- Prepare and deliver training on marketing, healthcare and regulatory legal and compliance areas.
- Liaise and coordinate with law firms on legal issues.
- Screen the external environment, alert management and assess and train on impact.
Profil recherché
Education:
• Law degree, obtained with excellent results. Supplementary degree or LLM considered an asset
Experience:
Minimum 5 years of experience in regulatory legal work in the life sciences industry, acquired in
• an international law firm or consulting/lobbying services organization,
• and/or legal department of an international corporation in the healthcare industry,
• and/or a relevant national European government body.
Knowledge and experience with other regulated products, such as medical devices, diagnostics, Advanced Therapy Medicinal products, or cosmetics is an asset.
Experience with US regulatory environment is a plus.
Profile:
Intelligent, entrepreneurial spirit, solution and business oriented, team player, result driven, self starter, assertive, strong listening and communication skills; able to manage strategic and complex matters; able to influence others from a non hierarchical position.
- Self starter with strong drive for results and strong sense of ownership.
- Comprehensive understanding of the healthcare industry, preferably medical devices and diagnostics, including industry laws and regulations, government contracting and tendering, anti kick-back, FCPA and other anti-bribery laws.
- Strong leadership skills and ability to drive projects forward to conclusion.
- Ability to work both independently and in teams, and to influence stakeholders, without having direct reporting lines.
- Have strong communication skills.
Languages:
- Excellent in written and oral English. Other languages are considered an asset.
