Regional Regulatory Strategist

£0.00 - £50.00 per hour
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
Surrey
Posting date: 07 Mar 2019
RA.PD.22057_1551963278

ProClinical is advertising a vacancy for a Regional Regulatory Strategist with one of the world's most prestigious pharmaceutical companies. The organisation specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas, including oncology, cardiology, and immunology. This is an exciting opportunity to join this historic company in their team in Surrey.

The Regional Regulatory Strategist will be accountable for CMC site transfers and other site-related change submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.

Job Responsibilities:

  • Ensuring transparency and excellence in evaluation, definition and execution of regulatory strategies.
  • Ensuring dossiers are produced and dispatched to assigned markets according to their defined filing plans and are submission ready.
  • Maintaining systems and databases per internal SOPs and policies.
  • Collaborating across the regulatory organization with stakeholders (such as the global regulatory lead (GRL) and the company Country Office to deliver efficiencies in Regulatory submissions and processes.
  • Managing CMC post approval manufacturing site transfer submissions for the EuCANZ Region (EU, EME and ANZ).
  • Managing post approval strategies (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL/GRS-CMC, PCO, Labelling team, and Submissions Management) to ensure a CMC submission ready dossier.
  • Communicating changes to regulatory requirements and updating the appropriate system in a timely manner.
  • Supporting planning and monitoring activities, updating timelines when necessary, and communicating changes to the relevant partners.
  • Authoring local submission components as needed.
  • Ensuring submission packages are reviewed against local CMC requirements for consistency and completeness.
  • Liaising with the manufacturing sites for obtaining supporting documents as needed.
  • Ensuring a thorough understanding and application of GRA procedures
  • Contributing to local and regional regulatory initiatives promoting a culture aligned with company values which supports compliance, innovation, and talent development and retention.
  • Ensuring internal regulatory processes and procedures are well documented.
  • Identifying and supporting efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
  • Understanding local regulations and trends for assigned markets.

Skills and Requirements:

  • A Bachelor's degree or equivalent in Chemistry, Pharmacy, or a related life-sciences field. An advanced degree may be an advantage.
  • Prior experience in the pharmaceutical industry or related in Regulatory Affairs, Conformance, or Compliance.
  • A strong knowledge/background of EU (EU and non-EU) regulatory procedures and requirements.
  • At least five years of experience in regulatory affairs or compliance, preferably in human medicines.
  • Demonstrable regulatory experience with a pharmaceutical company with proven examples of contribution.
  • Proven capability to manage Regulatory issues and consistently deliver to time, cost, and quality standards.
  • Regulatory experience including knowledge of Europe submission product lifecycle management processes.
  • Demonstrable experience of effective delivery in a matrix environment.
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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