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Senior Global Regulatory Affairs Manager

Salary:
62,797 P.A. ?
Location: Caversham
Company: MMS Holdings Inc.
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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.

General Responsibilities:

  • 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.
  • 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.
  • Key Activities:
    • Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
    • Communicates regulatory strategies as appropriate such that expectations are understood.
    • Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management.
    • Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
    • Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments).
    • Collaboration.
    • Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations.
    • Communicate and ensure alignment of regional management before GRT strategy decisions.
    • Partner with regional management and peers to ensure consistency in procedures and agency interactions.
    • Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
  • Regulatory Research:
    • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance.
    • Represents Regulatory Operations as the primary contact on global regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective/considerations at a project level in team meetings.
    • 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.
  • Health Authority Interactions:
    • 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.

Requirements:

  • 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.

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