Regulatory Affairs Manager

Job Ref: J27008
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 07 June 2018
  • Runcorn, Cheshire, England, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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To oversee the preparation and compilation of MAA's ensuring all documentation to the highest standard whilst adhering to all compliance guideline.

Major Duties and Responsibilities:

  • Oversee all regulatory affairs related project management of Marketing Authorisation Application (MAA) submissions and monitoring status of applications
  • Provide cross functional teams with regulatory input in order to obtain timely approvals and contribute to the product development and regulatory strategy planning.
  • Authoring of regulatory submission documents (Modules 1,2 and 3)
  • Compilation of full initial application dossiers for assigned projects in accordance with EU and US standards, as applicable.
  • Working with CMS document authors from other internal functions and external providers to ensure compliance with regulatory and company guidance / template specifications.
  • Co-ordination and preparation of responses to Regulatory Agency queries / deficiencies via close cooperation with other involved functions and liaison with Regulatory Agencies where required.
  • Participating in project launch meetings, review meetings and project team meetings as required. Liaise with CROs to ensure timings and compliance of clinical trials
  • Providing project specific regulatory strategic advice, technical expertise and coordination oversight
  • Prepare, review and maintain knowledge and understanding of SOPs and assist in the effective implementation of the MAH's Quality Management System.
  • Build business awareness of local regulatory requirements in the EU and international markets and provide regulatory advice, guidance and support to project teams, as required.

Requirements/Qualifications:

  • Life Science Degree. Master's Degree in Pharmacy or other similar Life Science discipline preferred
  • Extensive experience within Regulatory Affairs within the pharmaceutical industry, including directly dealing with regulatory agencies.
  • Exposure to eCTD format and electronic submission gateways is preferable.
  • Experience in the following would be advantageous - Inhalation dosage forms, Generic products, EU MRP/DCP submissions, US NDA/ANDA submissions.

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 589626

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.

SRG
07/07/2018 09:03:12
GBP .