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Regulatory Strategy Consultant

MMS Holdings Inc. is a global pharmaceutical service organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We support pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

MMS is looking to expand regulatory services for regions outside the US, particularly in the EU, Canada and Australia.  We are looking to add several regulatory strategists with experience in these regions to work with our clients who are planning to run clinical trials, file marketing applications and/or engage in regulatory activities with health authorities in these regions.  Key activities for regulatory strategists are included below:

Job Description 

  • Provide a wide range of high-quality global Regulatory Affairs services to pharmaceutical and biotechnology companies
  • Provide guidance globally for EU/EEC countries, Canada, Australia and ROW) for regulatory development of novel drugs in specialty therapeutic areas to include Rare/ Orphan disease areas (from early development covering CTA enabling studies to late stage phase 3 development), or for established drugs seeking new indications/ dosage forms for small biotech companies
  • Serve as liaison to regulatory agencies, conduct negotiations on behalf of sponsor teams, document decisions, and conduct debrief meetings; support multiple types of agency interactions/meetings (ITF, PIM, scientific advice, CTA/VHP, pre-MAA, advisory committee meetings, etc.)
  • Critical review and input into regulatory strategies and development of regulatory documents such as briefing packages, orphan drug applications, PIPs or other filings
  • Advise on regional submission requirements and prepare materials for regulatory submissions to allow for successful filings
  • Coordinate with MMS regulatory operations staff as needed to complete/submit filings according to agency requirements
  • May serve as Legal Representative (LAR) for sponsor in regions as needed
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