Sr. Associate Director / Director Regulatory Affairs

Location
Basel
Salary
92 - 110 CHF per hour (all incl)
Posted
08 Feb 2021
Closes
26 Feb 2021
Ref
49826
Contact
Jocelyn Blackham
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Senior Management
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 teams and 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 and marketing of launched medicinal products and associated medical devices.
- Exhibits strong leadership skills.

This is an excellent opportunity to join a global healthcare organization.

Please could you send any correspondence in English. Please quote reference 49826 in all correspondence.