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Job Details

Head of CMC & Pharmaceutical Development - Netherlands

Company: Barrington James Europe
Location: Netherlands
Closing Date: 05 May 18
Type: Permanent
Salary (£): Competitive
Benefits: Competitive

Job Summary:

Head of CMC & Pharmaceutical Development - Netherlands - Dutch speaking


Barrington James are exclusively retained with a small yet very experienced consultancy firm specialising in the development and registration of veterinary pharmaceuticals in Europe. As a consultancy they operate within a state-of-the-art pharmaceutical development laboratory, enabling them to develop a wide range of formulations in-house. This position works closely with both the Regulatory Affairs & Development functions internally to develop both new and generic veterinary medicines.

Job Summary:

The organisation are looking for a talented individual to lead the Regulatory Affairs and Pharmaceutical Development group. The objectives of this role are to design formulations, optimize processes, select and work with CMOs, oversee scale-up activities, write regulatory documents, and contribute to the overall pharmaceutical development activities – from preformulation to commercial drug product manufacturing and Regulatory Affairs – in multiple projects.

Key responsibilities:

  • Provide technical leadership in formulation development (in-house and external) and manufacturing activities of external partners (CMOs).
  • Evaluate, recommend, and direct outsourced API and/or drug product development with CMOs to complete formulation development; negotiate and manage contracts; 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.
  • Support (EU) regulatory submissions by preparing, reviewing and/or approving CMC sections (Part 2) of the dossier (including ASMFs), and ensure compliance with current regulatory requirements.
  • Prepare responses to regulatory authority information requests during the review process to ensure product approvals.
  • Maintain current knowledge of relevant regulations.
  • Lead, develop, coach and evaluate a team of experienced pharmaceutical development analysts.
  • Occasional travel required for interactions with clients, CMOs and other external partners.


  • MSc degree in Pharmaceutics, Chemistry or comparable scientific degree with a minimum 5 years of experience in the Pharmaceutical industry. Candidates with a BSc degree and extensive industry experience will also be considered.
  • Experience in building and managing pharmaceutical formulation development and manufacturing using internal and external resources.
  • Broad understanding of various formulation approaches, drug delivery methods, and routes of administration.
  • Knowledge of EMA regulations, (V)ICH guidelines and GMP to provide regulatory guidance to the development team.
  • Experience leading drug development teams is a plus.
  • Strong written and verbal communication and interpersonal skills.
  • Fluent in Dutch and English
  • Ability to work on multiple projects at the same time.
  • Hands-on individual with a collaborative personal style and the ability to work well in a fast-moving, multidisciplinary team.
  • Highly-motivated, organized, and detail-oriented.

Apply for this job: Head of CMC & Pharmaceutical Development - Netherlands

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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