Global Regulatory Affairs Manager (Remote - US)

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
 
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

We are looking for a full-time employee, remotely based within the US.

• Maintains a strong in-depth knowledge of applicable regulations and ICH guidances as well as regional specific guidelines where they exist.
• Expertise with MS Office, Adobe Acrobat, SharePoint applications, and eCTD viewer.
• Expertise tracking, reporting of central submission/approval progress, and archiving of all regulatory activity in applicable MMS systems.
• Provides strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH guidance and monitors the impact of changing regulations on submission strategies and updates, participating in implementation as applicable; Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Reviews, develops, gives advice on, and/or writes regulatory documents, meeting requests and regulatory responses for early stage/IND, NDA, BLA and/or MAA. Serve as the lead strategist for the original marketing application; oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Understands the eCTD submission process and how to work with Reg Ops and can answer questions for internal and external stakeholders with regard to the eCTD submission process; also, understands regional submission variation for marketing applications.
• Knowledge and advisement of expedited approval applications, orphan drug designation, meeting requests, and briefing docs and regulatory responses.
• Acts as POC for US regulatory submissions and ex-US Competent Authorities and coordinates across multiple regions for investigative and marketing applications.
• Advises on annual reports and coordinates multiple annual reports; also should have experience with post-approval safety updates.
• Advises on harmonization of US and Global submissions (e.g., VHP, coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.); determines optimal regional submission strategy for marketing applications.
• Coordinates with clinical CROs, local Authorized Agents and third party vendors on global regulatory submissions (overarching PM, managing versioning, coordinating responses to queries and information requests).
• Can optimize a clinical trial submission or marketing application submission strategy based on regional knowledge.
• Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Project Management:
  • Follows processes related to project management as appropriate for medical writing projects (e.g. close-out procedures etc.)
  • Manages project risks and timeline.
  • Effectively manages multiple projects and delegates as needed to complete projects on time.
  • Notifies project manager and line manager of changes to scope and timeline.
  • Provides oversight into the creation/maintenance of project plans and input for timelines."
• Participates and guides sponsor in meeting prep specifically for formal meetings with the FDA, marketing applications, and advisory committees.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
• Monitors impact of changing regulations on submission strategies and updates internal and external stakeholders; participates in implementation as applicable.

• Minimum of 5 years’ experience in Regulatory Strategy or similar field required.
• Expert knowledge of scientific principles and concepts. 
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications. 
• Hands-on experience with clinical trial and pharmaceutical development preferred.   
• Good communication skills and willingness to work with others to clearly understand needs and solve problems. 
• Excellent problem-solving skills. 
• Good organizational and communication skills. 
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.  
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.    
• Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.