Regulatory Affairs Manager (remote)

Hiring By - Biostaffic

ย BioPharma

United Kingdom

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details

Proclinical are recruiting for a Regulatory Affairs Manager to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

  • Contribute to RA team meetings, product team meetings and divisional meetings.
  • Attain a comprehension of the regulatory setting leveraging internal expertise and external regulatory intelligence.
  • Aid post-marketing actions for preparing regulatory proposals which might involve variations, PSURs/RMPs, replies to questions and renewals.
  • You will use and update regulatory information systems for planning, preparing, tracking and storing proposals to regulatory agencies.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a life science field.
  • Demonstrable experience in regulatory affairs.
  • Comprehension of regulatory needs for the EU centralised process and IC/GPS region.
  • Familiarity assisting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc. for the IC/GPS region.
  • Acquaintance working with document management systems such as RDMS and GPLM systems.
  • Capable of enabling/impacting and influencing efficient engagements and conversations.
  • Ability to engage to collate information and efficiently drive projects through to accomplishment to tight timelines.
  • A background and comprehension in science.
  • Communication skills both verbally and in writing.
  • Fluency in the English language.
  • An organised individual with the ability to work on various projects concurrently to meet tight timelines.
  • Works well in a team with analytical and assessment capabilities.
  • Works well under minimal supervision.
  • Able to resolve issues with the capacity to think tactically.
  • A high attention to detail.
  • Comprehension and relation to both external and internal customers.
  • Business aware with the ability to present self in a professional manner.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

#Regulatory

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • United Kingdom

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Proclinical Staffing
Proclinical Staffing

Current Openings: 0

At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe. Whether you are looking for a recruitment agency to support you with a single vacancy or you need to staff an entire new facility, we extend an expert hand to help you find the highly-skilled people you need. Operating exclusively within life sciences industry โ€“ from MedTech and Medical Devices to Pharma and Biotech โ€“ our experience, resources and dedication enable us to meet the unique needs of the competitive, fast-paced industry. Our worldwide connections match the rapid globalisation of the life science industry, with offices located throughout North America, Europe and the Asia Pacific region. Because each type of role requires a unique skill-set and understanding, Proclinical Staffing is comprised of specialist teams, each dedicated to recruiting for specific job functions. By specialising, our teams of consultants have a greater understanding of the roles that they are recruiting for, and are able to source the very best talent within the industry. Our specialist recruitment teams: + Regulatory Affairs + Clinical Research + Quality Assurance, Manufacturing & Validation + Medical Affairs & Physicians + Commercialisation & Business Development + Biometrics: SAS, Stats & Data Management + Computer Science & Data Science + Medical Writing & Medical Communications + Product Safety & Pharmacovigilance + HEOR and Market Access + Scientific & Preclinical + Technical Operations If you are currently hiring or considering taking the next step in your career, call us today on +44(0)207 44 00 637 or visit www.proclinical.com for more information or to submit your CV online.
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