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.

• 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.

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