Manager, Regulatory Affairs, International

Manager, Regulatory Affairs, International

Novasyte

Introduction/Purpose: The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several development projects into the international region. This role is key to driving both the Regulatory strategy and execution.

Key Responsibilities/Scope of the Job:

1. Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products.
2. Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead and country leads, for assigned products in development.
3. Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products.
4. Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams.
5. Provide strategic guidance on regulations and changes in assigned countries.
6. Support interactions with Health Authorities in assigned countries.

Position Qualifications:

Education/Learning Experience/Work Experience:

1. A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance).
2. Experience of regulatory requirements in countries outside the US and Europe.
3. Very good knowledge in written and oral English is required; knowledge of any other languages would be an asset.
4. Experience from leading projects and cross-functional teams.

Personal Attributes:

1. A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds.
2. Highly self-motivated and able to drive activities.
3. Excellent communication skills.
4. Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies.

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