Regulatory Affairs Specialist

ProductLife Group is seeking a Regulatory Affairs Specialist M/F responsible for ensuring the delivery of regulatory activities performed on the Benelux market.

**Responsibilities**
- Ensuring that the regulatory tasks and functions within the Regulatory Affairs Department are carried out efficiently and effectively
- Managing the new MAAs and post approval activities for Benelux market
- Obtaining and maintaining marketing authorization approval for the client’s pharmaceutical products
- Providing strategic regulatory input from local market
- Securing essential interface with authorities
- Maintaining strong and positive working relationships with the clients

**Profile and Skills**
- Similar experience of 3/4 years is mandatory
- Local expertise on BENELUX legislation
- Management of artwork generation, experience of promotional/non-promotional activities would be an advantage
- Experience of operating in EU context
- Good IT skills/knowledge
- Good organizational skills
- Fluency in Dutch and a good command of English are mandatory for business continuity.
- Proactive attitude and able to work on own initiative as well as part of a team
- Ability to prioritise different workloads/multi-task
- Personal responsibility for ensuring a high standard of work

**About us**

ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics. With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

**Job Type**: Permanent contract

Pay: From €45,000.00 per year

Schedule:

- Monday to Friday