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Regulatory Affairs Manager

  • Job reference: 925000
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 18/04/2019

Orion Group are recruiting for Regulatory Affairs Manager on behalf of our Multinational Biotechnology Client based in Cambridge for an initially 6-month contract

This role is:
*Based in the assigned region with interaction primarily on the GRT

This role reports to:
*A regional group leader

This role is accountable for:
*Executing the approved regional strategy for assigned programs
*Representing the region

This role is responsible for:
*Advising the GRT on regional considerations in developing a 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


Key Activities Strategy and Execution
*Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the 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

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 the product (e.g. IMR, PMCs, pediatric 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
*Regulatory Research
*Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products.
*Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
*Evaluates and communicate the impact of relevant regional regulations, guidance, current regulatory environment and competitor labeling
*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

Region Specific Activities
*US: Advises and supports promotion group regarding the applicability of data for product communication in the US
*EU: Review and approve promotional and non-promotional materials for use in the international region
*APAC, LACAN, EEMEA: Lead the product lifecycle for individual countries per national agency requirements
*APAC, LACAN, EEMEA: Work through the regional leads to manage distributor markets

Management
*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 the assigned team allowing appropriate prioritization of resources to achieve goals.


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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