Senior Regulatory Affairs Manager - Biotech - Cambridge

Talentmark Resourcing Solutions
13 Nov 2017
15 Nov 2017
Contract Type
Full Time
This is a fantastic opportunity for an experienced and professional regulatory affairs manager to join an innovative biopharmaceutical organisation. Based in Cambridge the midsize company builds out their Regulatory Affairs Team in the medical device space to complement their existing portfolio of Biologics and market leading Biosimilars divisions. The incredible company culture that promotes from within in a truly collaborative environment and offers great compensation.

Your main duties as Senior Regulatory Affairs Manager include

- Working with notified bodies
- Write, cmpile, submite Modul 3, CMC
- Life Cycle management (Variations, Submissions, Renewals, etc.)
- Submissions in EU, LatAm, MEA, APAC
- Mentoring & built out team within medical device / combination products

Your profile includes

- Extensive medical device experience
- Process driven, hands on mentality
- Life Science academic background
- Ability to adapt and new working environment quickly with pragmatic attitude
- Must have great time management and excellent organisation skills

Full job description and company details are available upon request application, apply below or contact Marian Engel to discuss in confidence.