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FSP - Regulatory Affairs Submissions Manager

United Kingdom, Remote Date posted 08/17/2022 Job ID R0000001067

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

We are looking for a client dedicated role as a Regulatory Affairs Registration Manager. You will be responsible for the maintenance of the worldwide vaccine licences by ensuring the planning/dispatch/submission/follow-up/approval of datapackages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc.

This role can be home or office based in various European locations.

Job responsibilities:

  • Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines

  • Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled

  • Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1

  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects

  • Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met

  • Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved

  • Ensure the tracking of relevant correspondence with Authorities

  • Communicate with external regulators on specific enquiries

  • Be responsible for Vaccine Registration activities of one or several projects - Identify key issues on registration activities that could prevent achieving objectives and proactively propose solutions

Skills and Expereinced required for the role:

  • University degree (preferably biological/chemical)

  • Ideally more than 3 years experience in the pharmaceutical industry; this should include at least 1-2 years RA experience.

  • Knowledge of Regulatory legislation in at least one geographic area

  • Basic understanding of biologicals/vaccines

  • Analytical capacity

  • Good organizational skills

  • Good communication and presentation skills

  • Fluent in English written and spoken


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