Senior Manager Regulatory Affairs F/M
Our client is an innovative and growing SME, specialized in developing and producing new biopolymers for cosmetics and pharmaceutical industries all over the world. We are looking for its Senior Manager Regulatory Affairs F/M in line with growth and expansion to new markets and countries.
Directly attached to the Chief Quality & Compliance Officer, your main missions are to:
- Develop and implement regulatory strategies to obtain product approval with optimal delay
- Manage a regulatory affairs specialist
- Identify risk in submission and escalate them to the management with mitigation proposal
- Identify and analyse issues that may impact the business; diligently and quickly advise colleagues as well as management accordingly
- Coordinate regulatory submissions and meetings with Authorities
- Interact with other departments (quality, operations, commercial, development…) to understand their own constraints
- Design all the non clinical studies and coordonate all the CROs requirements
- Work on special projects that require high level regulatory leadership for senior management
- Act as a CMC expert and advisor for finish product regulatory support for our customers
- Write regulatory file
The ideal candidate for this position in Regulatory Affairs would have a scientific background (PhD, PharmD), and have a minimum of 10 years of regulatory experience in the biopharmaceutical or medical devices industries, in an international enviromnent.
He must be familiar with CTD requirements and ICH guidelines, and must be used to work with health authorities.
He would have excellent interpersonal skills, excellent verbal and written communication in English, and leadership skills.
He would be able to work in an entrepreneurial, challenging environment and to multi-task and work effectively cross-functionally.