Regulatory Affairs Specialist
Offer
- a challenging job within a large pharmaceutical company
- a temporary assignment till 07-04-2025
- contract of Derks & Derks Secondment & Interim
Position
As a Regulatory Affairs Manager, you will be responsible for coordinating and supporting all regulatory activities to maintain registrations for the company’s product portfolio within the EU. This includes procedures such as the Centralized, Mutual Recognition, Decentralized, and National Authorized Procedures across various therapeutic areas.
Your primary responsibility is to ensure the maintenance of European Union marketing authorizations for assigned products through the timely preparation and submission of all required post-approval applications and variations. You will support and coordinate regulatory activities in the EEA, Switzerland, Great Britain, and non-EU EESC countries. In addition, you will develop and implement regulatory strategies for registered products, new development projects, and marketing authorization applications.
You will maintain close relationships with EU regulatory agencies, the EMA, and Country Regulatory Affairs, ensuring you are always up to date on relevant EU regulations and guidelines. Furthermore, you will represent Regulatory Affairs Europe in various project teams.
Profile
- a minimum of a Bachelor’s degree in Pharmacy or another relevant Life Sciences field
- at least 2 years of experience in the pharmaceutical industry in a similar regulatory position
- demonstrable knowledge of EU regulations and procedures such as CP, MRP, DCP, and NAP
- strong organizational and planning skills, with the ability to manage multiple projects and meet deadlines
- excellent oral and written communication skills, fluency in English is required; knowledge of additional languages is an advantage
- solution-oriented, detail-focused, and able to work effectively in an international and multidisciplinary environment
- proficient in MS Office and regulatory tools
Organisation
Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Oss.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/24-296-DD, to Annerien Peters: info@derksenderks.nl. For further information, please call Annerien at number +31 (0)6 45403933.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.