Regulatory Affairs Manager CMC - Growing animal health company!

Are you experienced with RA and CMC and do you have a background in pharma, biotech or animal health? My client, focused on animal health products offers is looking for a RA manager to manage and grow a small team. This means you have a lot of growth opportunity within this company. Are you ready for a new challenge in return of a great compensation package? Then this opportunity might be the one for you.

Responsibilities

In this function your general responsibilities would be; provide management of the Regulatory Professionals or equivalents in the delivery of their RA activities; provide technical expertise in Regulatory Affairs and in particular CMC elements of product maintenance; work collaboratively with other critical business functions including DPM/ Supply chain, Quality and commercial; communicate to RA management on all areas of responsibility on a regular basis; support the Head of Regulatory Affairs in driving RA process improvement and increase RA expertise within the team

Key Responsibilities would be; being responsible for obtaining and maintaining marketing authorisations, including providing documentation for distribution partners; assisting with Technology Transfers between internal and external manufacturing sites; providing a source of Regulatory CMC expertise to the Regulatory Professionals and the wider RA group; being responsible for coaching and training other RA Professionals in Regulatory and CMC elements of the role, including optimal submission strategies, risk management and dossier remediation activities; remaining vigilant to changes in the EU Regulatory landscape and highlight key risk areas as they emerge to management.

What we are looking for:

• University degree in veterinary science, pharmacy, chemistry biochemistry, chemical engineering or other related discipline;
• At least 5 years regulatory affairs experience in a similar role (Animal health, Pharma, Biotech)
• Fluency in written and spoken English and Dutch
• Established leadership skills (motivation, communication, change management, collaboration)
• Strategic thinking and creative problem solving

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via S.Thijs@nonstopconsulting.com. You can contact me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!