Company: Key People Limited
Closing Date: 08 Dec 16
Salary (£): 40,000 - 60,000
Benefits: bonus and benefits
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join one of the world's largest Pharmaceutical companies within their global OTC Regulatory team. You will be mainly focusing on new submissions on a global scale.
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join one of the world’s largest Pharmaceutical companies within their global OTC Regulatory team. You will be mainly focusing on new submissions on a global scale.
Within this role you will work as a Regulatory Manager in the central OTC Regulatory Affairs department, specifically working with OTC medicinal products. The success of the OTC team has been outstanding to date and will continue to flourish in the near future due to ambitious project plans for 2017.
Skills & Experience:
- To be considered for this role you will be educated to BSc (Hons) level (or equivalent)
- Significant experience within OTC Regulatory Affairs.
- Experience in the registration of OTC (human medicinal) products in the EU and international markets will be required to be considered for this role.
- Lead the registration process for new Marketing Authorization Applications
- Manage new MAAs submitted via DCP, MRP or Nationally
- Assist the OTC Associate Director for New Submissions in development of registration strategies.
- Ensure that dossiers are compiled and dispatched in accordance with work plan commitments and internal KPIs
- Develop and maintain thorough and up-to-date understanding of the European and other regions regulatory environment: provide early input to multi-functional team on new initiatives and plans
- Close interaction with other functions across R&D to gain early visibility of dossier content, identify risks and propose corrective actions
- Actively work on launch critical post-approval variations for authorised products until project is transferred to Central Maintenance & Compliance Team
- Provide central RA support to countries and regions
For further details about this role, or for a confidential discussion about other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org
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