Vice President, Head of Regulatory Affairs

vor 1 Tag

Bern, Schweiz NonStop Consulting Vollzeit

On behalf of a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition we are currently looking for a Vice President, Head of Regulatory Affairs for their Biosimilars BU.

**Activities**:
Responsible for directing global regulatory strategies for assigned projects and programs.
Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
Provide regulatory guidance to company personnel throughout the research and development process, approval and post approval phases
Direct the organization and preparation of clear and effective submissions.
Prepare and deliver effective presentations for external and internal audiences.
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development.
Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
Coordinate relations and alignment with local/regional regulatory experts.
Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
Actively promote relationship building between the ROW team, distributors and commercial teams.
Direct the ROW filing strategy for new submissions

**Qualifications**:
8 years pharmaceutical/biotechnology industry experience with technical management experience.
Minimum of 6 years in Regulatory Affairs.
Good knowledge of applicable regulations.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Experience in European regulatory pathways for Biosimilars and previous experience in filing Biosimilars. Experience with FDA is a significant plus
**Location**: Switzerland

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

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