MMS Holdings Inc. Regulatory Strategy Consultant in Philadelphia, Pennsylvania
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .
MMS is looking to expand regulatory services within the US. 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:
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
10+ years pharmaceutical industry specific experience
Experience in ophthalmology a plus
Hands on support with regulatory applications, IND, NDAs, MAA, CTAs, etc (drugs and biologics), device is not as great a need
Health Authority interactions, scientific meeting, etc.