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Regulatory Affairs Senior Manager

  • Job reference: 926753
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/07/2019

Hello all. I am currently seeking a Regulatory Affairs Senior Manager for an initial 12-month contract with our client in the Cambridgeshire & Middlesex area. Please contact me at Andreia.Terron@orioneng.com for more details

Regulatory Affairs Senior Manager

Description: To ensure that the client acquires and maintains all the required licenses in order to support clinical trials for investigation medicinal products as well as market commercially approved medicinal products. To 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 (dependent on grade). This role is based in the assigned region with interaction primarily on the GRT. This role is accountable for executing the approved regional strategy for assigned programs and representing the region.

Primarily responsible for Regulatory Affairs Senior Manager activities, which may include any/all of the following:

  • Advising the GRT on regional considerations in developing strategy
  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • May participate as a member of:
    Global Regulatory Team (GRT)
    *Global Development Team (GDT)
    *Clinical Study Team (CST)
    *Label Working Group (LWG)
    *Regional Teams
  • Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the client's portfolio in compliance with global filing plans and local regulatory requirements
  • 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 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 by collaborating with the Labeling Working Group 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 GDT on regulatory implications and requirements related to global clinical development plans and objectives
  • 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, pediatric and other agency commitments)
  • 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
  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the client's products
  • 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
  • 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
  • Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
  • Review and approve promotional and non-promotional materials for use in international region
  • Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
  • Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.

Basic Qualifications

  • Looking for an all-rounder, who is flexible and willing to work across areas, including but not limited to: - pediatric plans - drugs in development - variations - new line extensions - post marketing
  • Must be personable
  • At least 10 years' experience that includes: - strategic management - providing key scientific advice to team - EU centralised focus - EU legislation and guidelines - up to date to current key regulatory topics

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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