Description
Regulatory Affairs ManagerLocation: Berkshire
Salary: Competitive
This position is responsible for providing guidance for, and management of regulatory activities with health authorities and local government regulations in UK, Ireland, Malta and Nordics countries: Denmark, Finland, Norway, Sweden and Iceland.
Responsibilities:
- Ensure the registration and regulatory compliance of locally marketed products to bring competitive advantage to our brands. Amend registration dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims.
- Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware and informed early enough of significant regulatory expected changes and potential issues.
- Support regional management and commercial team and assist EU regulatory director, to manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorisations (MA), price agreements and appropriate licenses/authorisations.
- Liaise directly with local health authorities to develop and lead NEU regional regulatory strategies for product categories in line with global strategic plans.
- To take leadership within a cross functional management team to drive forward regulatory projects and initiatives for the region
- Possessing a strong knowledge and understanding of pharmaceutical regulations concerning the narcotic drug business in individual European countries and surrounding regions. Thorough familiarity with the process of obtaining and maintenance of pharmaceutical MA approvals & narcotics licenses, MA variations, and Aggregate report reporting.
Professional Qualification / Experience / Specialist Requirements
- Advanced degree in science-related field.
- A minimum of 5 years experience in the pharmaceutical regulatory is required.
- Working knowledge of key health authorities in Northern EU and surrounding eastern European countries.
If you are keen to hear more please contact our Senior Regulatory Consultant Natalie Hopkins at n.hopkins (a) realstaffing.com directly with your C.V or call to reach her.