Sr. Associate/Manager Regulatory Affairs

Sr. Associate/Manager Regulatory Affairs

Zoetis

Zaventem, Belgium

Key responsibilities follow:

• Planning, preparation, submission and support of regulatory applications in EU for designated projects/products in different therapeutic areas, including new Marketing Authorization applications, line extensions, variations, clinical trial applications, generic applications, scientific advice and MRL applications. This work may include, but is not limited to:
  • Ensuring compliance with current legislation (national, mutual recognition, decentralized or centralized procedures) and regulatory guidelines.
  • Coordinating the preparation and submission of responses to questions raised by regulatory authorities.
  • Preparation and modifications of the Summary of Product Characteristics and labelling text.
  • Acting as the company representative for specific regulatory applications and, where required, acting as signatory of relevant documentation.
• Serve as EU regulatory representative on multidisciplinary Project Teams responsible for developing new veterinary medicinal products, including early phase projects. In this role the successful candidate will contribute to the development of regulatory strategies, to advise partner groups about suitable product profiles, label claims and data requirements to support future registration applications.
• In order to support development and maintenance of in-line veterinary products, the Senior Associate/Manager Regulatory Affairs will liaise directly with the EU regulatory authorities and internally with colleagues from regulatory CMC, Artwork, in-country regulatory affairs, publishing, pharmacovigilance, commercial development, safety and clinical efficacy departments.
• Help provide regulatory support for geographic expansion, especially in those cases where non-EU activities are concurrent with (or based upon) EU authorization activities.
• Provide regulatory support and advice regarding Global Manufacturing initiatives and Commercial market enhancements.
• Participation in departmental activities.
• Other specific duties and responsibilities as detailed in Goals or agreed with Line Manager.
• Where appropriate all these activities may be completed with the guidance of a more experienced regulatory colleague(s).

Qualifications (Training, Education & Prior Experience):

• A Master of Science (MS) or similar advanced degree in biology or other related science (Pharmacology, Microbiology, Veterinary Science, etc.). A DVM or a PhD in a relevant discipline is desirable.
• For the manager position, a minimum of 5 years of practical experience with human or veterinary medicinal products, preferably in regulatory affairs. For the Senior Associate position, candidates without prior regulatory experience may be considered.
• Demonstrated abilities in areas of interpretation and regulatory requirements and procedures. Working understanding of relevant EU legislation and processes.
• Understanding of the (veterinary) medicinal product development process, including early and late-stage development activities.
• Knowledge in one or more of the following areas relevant to veterinary medicinal products and/or feed additives is highly desirable: toxicology and safety assessment of novel products, human food safety including MRLs, clinical efficacy studies.