Accessibility Links

Regulatory Affairs Consultant

  • Job reference: 920703
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 17/07/2018

OrionGroup are looking for a Regulatory Affairs Professional for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 11-month contract.

Main responsibilities of the role

Input in development, post-approval and life cycle management
* Participate in global regulatory team meetings as appropriate;
* Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
* Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

Liaison with Regulatory Agencies and Local Operating Companies
* Act as back-up for contact with Regulatory Agencies as needed;
* Draft cover letters for Regulatory Agency communication;
* Assist in the preparation of meetings with Regulatory Agencies;
* Liaise with LOCs, track and respond to queries in a timely manner.

Input in document and process development
* Assist in development of processes related to regulatory submissions;
* Draft and review some document content (depending on level of regulatory knowledge/expertise)
* Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed;
* Track dates of submissions and Regulatory Agency responses.

Clinical Trial Applications (CTA)
* Review protocols and ensure alignment with regulatory requirements;
* Advise team on required documents and submission strategies in preparation of CTAs;
* Ensure CTA submission packages are complete and available according to agreed timelines;
* Review and approve clinical trial supply plans.

Marketing Authorization Applications (MAA)

* Advise team in required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
* Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities;
* Assist with submission and acceptance of MAA;
* Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.

Desired Background and Skillset of the successful candidate:

  • Understanding of the drug development process and regulatory submission and approval process
  • Knowledge of the regulatory environment, guidelines and practices of EMEA regions.
  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience;
  • Experience in regulatory affairs;
  • Teamwork experience.
  • Able to work successfully within a team environment and as an individual contributor;
  • Project management skills;
  • Oral & written communication skills;
  • Organisation & multi-tasking skills.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

Similar jobs
Regulatory Clinical Trial Application Submissions Manager
  • Salary Negotiable
  • Job type Contract
  • Location High Wycombe, Buckinghamshire
  • Description Orion Group are currently recruiting for a Regulatory Clinical Trial Application Submissions Manager on a 6 month contract basis (with potential to be extended) for our Multinational Pharmaceutical