Sr. Associate Director / Director Regulatory Affai
Jocelyn Blackham is recruiting for a Senior Associate Director / Director of Regulatory Affairs to join a global pharmaceutical company in their digital healthcare solutions team, partnering with tech startups and people passionate about disrupting healthcare. The role will be based at their site in Basel on a contract basis for 12 months.
The main purpose of the role will be to:
- Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
- Provide regulatory leadership on digital tools development supporting global and local commercial/development teams in alignment with company approach and engaging with external partners.
- Act as global regulatory contact with local teamsand connect with other internal experts to provide coordinated, cross-functional guidance and support to (Global/Local) business units and partner companies to enable them to get beyond the pilot stage of digital-enabled products as they seek to onboard, test and scale digital partnerships.
Further responsibilities will include:
- Developing high quality regulatory strategy for selected global projects.
- Supporting key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs,drug dossiers and device clearance planning processes. Identifies requirements, issues, gaps, and trade-offs affecting optimal and timely registration/clearance., for assigned projects.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred).
- Experienced in leading teams in health authority negotiations and regulatory submissions, and in driving good regulatory practice for in-market pharmaceuticals, having key awareness of the variety of regulatory diversity around the globe for promotion andmarketing of launched medicinal products and associated medical devices.
- Exhibits strong leadership skills.
This is an excellent opportunity to join a global healthcare organization.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email email@example.com. Please could you send any correspondence in English. Please quote reference 49826 in all correspondence.