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.
- Full Time
- Travel: Yes
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"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
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
Subject Matter Expert in
Submission writing/Technical writing pertaining to Pre-Investigational New Drug authoring(IND), IND/IMPD authoring and/or New Drug Application (NDA)/Biologics License Application (BLA)
Reviewing/Preparation of the clinical regulatory documents for Innovator products (new filings/hybrid filings) listed below, not limited to:
Briefing documents/meeting packages
General investigation Plan
CTD modules such as Module 2.5 (Clinical overview), Module 2.7(Clinical summary and tabulations including Summary of Safety (ISS), summary of Efficacy (ISE)
Preparing/reviewing responses to heath authority queries
Masters in pharmacy/PhD/BDS/MBBS, advanced degree preferred
Around 15 years of overall experience in Industry/regulatory domain with knowledge Biologics/Biosimilars
Therapeutic area knowledge : Oncology, Immunology, Cardiovascular, targeted therapies etc.
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