Regulatory Affairs Manager, Emerging Markets

Job content

An excellent opportunity has arisen for an experienced Regulatory Consultant with strong Emerging Markets strategy experience to join my cline ton a 12-month contract basis.

This role has been assessed and falls INSIDE IR35.

Within this role, you will essentially ensure optimal strategy across EMEA Emerging Markets countries and will report to the Senior Director, Reg Affairs EMEA EM. You will be accountable for the Regulatory Submission strategy, regulatory compliance and continuous improvement within the market scope.

Main Activities

• Provide support to EM network for proper execution of the regulations enforced by HA Health Authorities
• Acts as a LOC liaison and delegate for the Senior Director head of EM as appropriat
• Problem solver coach for LOC RA team with decision making mandate as required
• Contribute to maintaining and disseminating the regulatory activity metrics and intelligence foundation and framework that establishes a systematic approach in implementing new regulations in liaison with the EMEA EM RA projects Manager
• As required manage, lead, execute continuous improvement projects within RA which could be providing cross functional subject matter expertise or directing EM, GPH projects within RA in liaison with RA EMEA EM PM
  

Continuous Improvements

• Independently manages, plans, and directs all aspects for the successful design, sponsorship or lead of RA business support improvement or excellence side initiatives which are additional to those manages by team PM. Ability and mandate to make strategic decisions as the delegate for EMEA EM RA head for both commercial and GPH scope.
• Development and deployment of standard work for Continuous Improvements across the EMEA EM RA network by utilizing organization’s available toolkits at our disposal to assist the EM RA network with the selection of the right tools including but not limited to operational excellence and Compliance and to enable effective and efficient submission execution and life cycle management
• Supports the SD in the development of the future state staffing model for the team to support the business needs and in alignment within the EMOC & GPH LRFP and GRA strategic refresh as needed.
• Provides coaching and mentoring for staff, assesses any gaps in the team and develops action plans to address the gaps including diverse and inclusive staff development
  

Strategic Initiatives

• Stays current with regulations / guidance’s in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams, company’s consultants and Business Partners.
• Could be asked to evaluate new business development opportunities for Emerging Markets and / or participates on due diligence teams.
• In coordination with local regulatory lead and EMRL provides strategic guidance / advice on emerging trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs e.g., external shaping obo of the Sen Director – as delegate
• Manages, trains, provide direction, strategic guidance and solutions to projects to direct and indirect reports and / or mentors team members, if required, to support scope of project work.
• Partner with the LOC RA colleagues, regional/LOC market access and launch excellence team to understand end to end pharma value chain topics and support opportunities to drive consolidated inputs into regional product development plans.
  

Compliance

• Works with EMEA RA compliance director to ensure regulatory compliance EM- GPH Support
• Identifies and develops the SMEs accountable for providing supports in continuous improvement projects and compliance matters and implements regular trainings available to the global teams to ensure building knowledge base re the EMEA region for commercial and GPH scope regulatory activities with particular support to LOC teams
• Support on local RACI and ways of working to provide best interest cross functionally and for RA.
• Could contribute or lead if needed, any integration projects between GPH and EMEA EM commercial RA ways of working to find efficiencies and operational excellence across clusters and TAs.
  

Required Experience

• Education Bachelor or master’s degree in an appropriate scientific field of study. Preferred fields of study include Pharmacy, Biology, Chemistry, Business at Master level
• 10+ years of experience in regulatory roles within the pharmaceutical industry
• Good business acumen
• Strong knowledge of Health Authority regulations (EMEA with focus on EM and associated complexity), cGMP, ICH, and other
• Experience with continuous improvement, change management and business process reengineering, principles of Six Sigma and lean practices or general project management.
  

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk