Regulatory Regional Strategist - CMC

Job Ref: J25315
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 05 February 2018
  • Surrey, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

To be accountable for CMC site transfer submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management.

Primary responsibilities:

  • Manage CMC post approval manufacturing site transfer submissions for the Europe Region.
  • Manage post approval strategy and execution in alignment and partnership with key stakeholders to ensure a CMC submission ready dossier.
  • Communicate changes to regulatory requirements and update the appropriate system in a timely manner.
  • Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners.
  • Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.
  • Liaise with the manufacturing sites for obtaining supporting documents as needed.
  • Ensure thorough understanding and application of PEH RA procedures.
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
  • Assist in ensuring internal regulatory processes and procedures are well documented
  • Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
  • Ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
  • Maintain systems and databases per internal SOPs and policies and author local submission components as needed.
  • Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead (GRL) and the country regulatory lead (CRL) to deliver efficiencies in Regulatory submissions and processes.

Qualifications:

Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Experience:

Experience in regulatory affairs or compliance preferably in human medicines

Regulatory experience including knowledge of Europe submission product lifecycle management processes.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.