Director CMC (MT member).
Regivet BV is a consultancy firm specialised in the development and registration of veterinary pharmaceuticals in Europe. At the office in Spoordonk (Oirschot), a state-of-the-art pharmaceutical development laboratory is located, enabling them to develop a wide range of formulations in house. A team of experienced Pharmaceutical Development Analysts and CMC Regulatory Affairs Managers work together with the Veterinary Regulatory Affairs & Development department to develop both new and generic veterinary medicines.
As one of the few veterinary CRO’s Regivet BV can –together with external partners– offer the complete development package for veterinary pharmaceuticals, starting from a basic product idea up to a national or a European product authorisation.
Job omschrijving.
You will lead and motivate the CMC group (Pharmaceutical Development and Regulatory Affairs) and contribute to the overall pharmaceutical development activities – from preformulation to commercial drug product manufacturing – in multiple projects. In addition you will optimize internal processes and manage regulatory strategy and activities. You are responsible for the selection and communication with CMO’s and overseeing scale-up activities.
You will
- Lead, develop, coach and evaluate a team of experienced pharmaceutical development analysts and CMC-RA managers (12 fte).
- As member of the management team, collaborate with the other members of the management team to define and execute both short and long term strategic goals of the company.
- Provide technical and strategic leadership in formulation development (in-house and external) and manufacturing activities of external partners (CMO’s).
- Evaluate and recommend, direct outsourced API’s and/or drug product development with CMO’s to complete formulation development; build effective on-going relationships.
- Develop and execute project plans to support overall development objectives.
- Work in a multidisciplinary team to develop optimal formulations meeting both pharmaceutical and end-user (veterinarian, animal owner) requirements.
- Provide technical guidance to the CMC-RA managers for (EU) regulatory submissions by reviewing and/or approving CMC sections (Part 2) of the dossier (including ASMFs), and ensuring compliance with current regulatory requirements.
- Maintain current knowledge of relevant regulations.
- Occasional travel required for interactions with clients, CMO’s and other external partners.
Profiel van de kandidaat.
Regivet is looking for a talented candidate with:- A MSc degree in Pharmaceutics, Chemistry or comparable scientific degree.
- A minimum of 10 years of experience in the Pharmaceutical industry.
- A BSc degree and extensive industry experience will also be considered.
- Experience in pharmaceutical development, analytical methods and manufacturing.
- Broad understanding of various formulation approaches, drug delivery methods and routes of administration.
- Knowledge of EMA regulations would be nice.
- Proven people management / leadership skills (team player, create trust).
and who is:
- Hands-on with a collaborative personal style and the ability to work well in a fast-moving, multidisciplinary team.
- Strong in written and verbal communication and interpersonal skills.
- Has the ability to work on multiple projects at the same time.
- Highly-motivated, organized and detail-oriented.
- Fluent in English and Dutch.
Contact.
For further information please contact:
Marjo Lucker, Recruitment Consultant
T: +31 613 561 988
E: lucker@themagroup.eu
Marije Hoogendoorn, Sr. Recruitment Specialist
T: +31 623 135 118
E: hoogendoorn@themagroup.eu