Job title: Senior Global Regulatory Affairs Manager – Hybrid Role (Remote)
Company: MMSH Clinical Research Pvt Ltd
Job description: MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, 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 the company has been recognized as a leading CRO in Global Health & Pharma s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn .
- Responsible for working with internal and external teams, as well as vendors, to manage short- and long-term global regulatory activities that support the success of investigational and marketed pharmaceutical products throughout their lifecycle, including the compilation, preparation, coordination, review, and submission to Health Authorities.
- Ensure regulatory compliance, with a focus on patient safety. As requested, this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff.
- Ability to support writing and mentoring activities for Briefing Documents, Meeting Requests, and other Module 1 documents.
- Key Activities Strategy and Execution:
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements. Coordinates with Sponsors and Regulatory Operations Team on the management of large submissions.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with global regulatory Team (GRT) strategy.
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
- Directs the development of the regional product label to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities.
- With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives.
- Health Authority Interactions:
- May act as contact and create relationships with agency staff on specific product assignment.
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management.
- Works with cross-functional teams to coordinate regulatory agency (RA) and other central or country level authority submissions to ensure timelines are met.
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy includes contingency regulatory planning/risk assessment Works closely with the publishing team by providing deliverables to publishing once submission ready documents are received.
- Graduate degree preferred in related discipline/industry or significant industry experience.
- 5+ years experience in pharmaceutical or CRO industry preferred.
- Expertise with MS Office, Adobe Acrobat and SharePoint applications.
- Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Prior experience in CROs/ Pharmaceutical Services, scientific & clinical data/terminology, and the drug development process a plus.
- Strong organizational skills and extremely detail oriented.
- Efficient time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines.
- Strong written and verbal communication skills.
Job date: Tue, 04 Jan 2022 08:15:08 GMT
Apply for the job now!