Regulatory Affairs Manager

JOB PURPOSE

Drives effective regulatory activities within organization as well as global organizations, to support the development of new products and maintain the existing portfolio, provides strategic regulatory input into preparation and handling of health authority submissions, leading to timely approvals with best possible labeling, including their maintenance and life cycle management.

MAJOR ACTIVITIES

- Works closely with global and local colleagues from DRA and other relevant line functions to advise and agree on local regulatory strategy, clinical development plans and deliverables. Participates actively in local brand teams and global DRA subteams. Proactively builds internal relationships to local and global functions (eg to Business Franchise/BU, ICRO/GMO, Market Access, Pricing and Reimburesement, Marketing, TechOps, DS&E) to meet business needs and to ensure regulatory input for all market access and launch readiness plans, including regulatory aspects of compassionate supplies. Provides regulatory advice to internal local and global business partners on all regulatory aspects of development and life cycle related activities. If required, provides regulatory competitor intelligence for Switzerland.
- Critically evaluates and discusses regulatory strategy, timelines, data and rationale with local and global teams to define and eliminate prior to submission possible project deficiencies, thereby ensuring timely approvals of marketing authorizations, and life cycle related applications
- Proactively establishes and maintains relevant contacts to health authority stakeholders. Where applicable organizes and participates in Swissmedic meetings to support product development programs. Participates in workshops and working parties to further improve the collaboration with Swissmedic and ameliorate internal processe Monitors changes and future trends related to regulatory issues.
- After completion of internal approval processes ensures that submissions to health authority are made in accordance with Swissmedic regulatory standards within appropriate timeframes, including PSURs, DSURs and RMPs, notifications on marketing and de-registration status of registered products. In case of transfers of Marketing Authorizations to another entity or third party supports transfer application and manages transfer of regulatory dossier.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.