Scientific Specialist (Pharmaceutical Quality)

Job

In this role you will:

• Provide scientific specialist support in relation to the following areas:
  • Development and evaluation of Module 2 and 3 quality aspects of medicinal products for human use across the product life cycle (preauthorisation, initial MAA and post-authorisation);
  • Management of requests for scientific advice, protocol assistance, parallel scientific advice of quality aspects of human medicines with a focus on biological active substances;
  • Lead the development of regulatory and/or procedural guidance documents in the area of quality of medicines with a focus on biologicals and provide training as required;
  • Pharmaceutical quality aspects of innovation and advanced manufacturing technologies for medicinal products of biological origine for human use in the context of the Quality innovation group;
• Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc. on pharmaceutical quality aspects of human medicinal products of biological origine;
• Respond to the requests for information received by the EMA on pharmaceutical quality matters.

Read full description and requirements here: Scientific Specialist (Pharmaceutical Quality) Job Details | EMA

Profile

To be eligible for consideration for this position, you are required to meet the following conditions:

• enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
• have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
• have fulfilled any obligations imposed by applicable laws concerning military service.
• possess a university degree (minimum of three years) in Pharmacy, Biology, Chemistry, Biochemistry, Engineering or other relevant life-science disciplines that must have been obtained by the closing date of this vacancy notice,
• have at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date of the publication.

Read full description and requirements here: Scientific Specialist (Pharmaceutical Quality) Job Details | EMA

Benefits

• Initial 5 year contract.
• competitive monthly tax-free salary (6961.29 Euro based on a fulltime contract (40hrs/week), plus benefits like expatriation or household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan

Company profile

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and safety monitoring of medicines.

At EMA we foster scientific excellence in the evaluation and supervision of medicines.

EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a community of around 450 million people living in the EU, and has been operating since 1995.