Back to job search

RA CMC Associate Manager

  • Location:

    Puurs, Belgium

  • Contact:

    Amandine Planche

  • Job type:

    Contract

  • Contact phone:

    +32 10 68 53 30

  • Industry:

    Pharmaceutical , Life Sciences

  • Contact email:

    amandine_planche@oxfordcorp.com

Are you an experienced "Regulatory Affairs CMC" professional, fluent in Dutch and English, with a degree in science and looking for a new opportunity ? Then this mission at our client in Puurs may be what you are looking for !

Job Description

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Responsibilities

  • Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle.
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Establish and maintain sound working relationships with partners and customers.
  • Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Requirements

  • Bachelor or Master degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Fluent English and Dutch required (oral and written).
  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable.
  • Ability to critically evaluate data from a broad range of scientific disciplines.
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
  • Effective planning, organizational and interpersonal skills.
  • Reasonable approach to risk assessment.
  • Excellent written/spoken communication and negotiation skills.
  • Computer literacy.

Benefits

  • Full-time Position
  • A balanced salary package based on your capabilities and experience


Existing right to work in Europe required ( please read job spec in full before applying ).

Vacancy number: 18010