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von: Kelly Services (Schweiz) AG | localité: BaselN: KellyServices(Schweiz)AG
For our client, a pharmaceutical and biotechnology company we are looking for a:
Sr. Manager Regulatory Affairs-EEMEA
The Sr. Manager of Regulatory Affairs-EEMEA based in Basel, Switzerland will provide regulatory support to the Sr Director Regulatory Sciences – EMEA and the International Regulatory Project Leads. This role is intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in supporting the Health Agency interactions internationally for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager will provide regulatory support across different functions. The support includes but is not limited to requesting Scientific Advice meetings at the national level, managing the marketing authorization applications and post-approval activities for selected countries.
Your Tasks:
- Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments for selected international markets
- Work with the International Regulatory Lead, Global Reg-CMC and the Sr Director Regulatory Sciences – EMEA, on the development and execution of regulatory strategy in selected countries
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects and countries
- Identify and assess regulatory risks for assigned projects or programs
- Interact with partners and Health Authorities as appropriate
- Ability to work both independently and within project teams, committees, etc. to achieve group goals
- Prepare and deliver effective communications and presentations for external and internal audiences
Requirements:
- Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
- 5+ years of experience in the Pharmaceutical industry. 3+ years of experience in Regulatory strategy
- Experience in the Middle East a plus
- Strong knowledge of current EU and International regulations
- Strong experience with CTD format and content regulatory filings
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Ability to work independently to manage multiple projects in a fast-paced environment
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
- Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management, as relevant
- Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
- A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Please apply online. For futher information please contact your Kelly recruiter Judith Atgé Martin (0041612708015)
