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FSP Senior Regulatory Affairs Consultant - CMC vaccines

Poland, Remote Date posted 09/23/2022 Job ID R0000003863

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 currently looking for a client dedicated Senior Regulatory Affairs Consultant with CMC vaccines experience.

In the role of a RA Senior Consultant you will develop specialist knowledge of a particular subject matter or market. You will provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You may serve either as an individual contributor, a workstream lead or provides overall project leadership. You will ensure the timely performance of work within a project scope to the quality expectations of PC and the client.

This role can be based in Poland, Hungary, Romania or Lithuania - office or home based.

Job Responsibilities:

  • Coordination/authoring of Module 2.3 and Module 3 dossiers, including new registration dossiers of 2 new vaccines, minor and major variations on various products with declination to other markets, renewals, PQVAR, US and CA Annual Reports

  • Coordination of CMC Module 1 submission, including WHO submissions, PQVAR activities, APR for all products

  • Lead/Coordination of a team of CMC professionals

Skills and Experience required for the role:

  • University degree in a science discipline

  • At least 7 years CMC vaccines experience

  • SME M3 Authoring Experience

  • Specific CMC LCM expertise in supporting Major/Minor Variations, Renewals and HA RTQs, M1 authoring

  • Working knowledge of Regulatory Systems (Veeva Vault, Veeva RIM, etc.)

  • Very good project management skills

  • Fluent English, French language skills are a plus


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