Regulatory Affairs Director - Emerging Markets

£0.00 - £700.00 per day
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 29 Apr 2019

ProClinical is advertising a vacancy for a Regulatory Affairs Director -Emerging Markets position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities:

  • Accountable for the development and implementation, at a regional International of innovative regulatory strategies for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients. Strategy should reflect applicable (inter)national requirements.
  • Leads the development, communication and updates of the International section of the Regulatory Strategy Document (RSD) for assigned products/projects.
  • Ensure appropriate x-functional consultation, in particular with International Commercial, peer review and senior stakeholder endorsement.
  • Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
  • Lead be part of the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
  • Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional Product Teams.
  • Leads the planning and construction of the International dossier.
  • Leads the development and implementation of an optimal regional (International) regulatory strategy for a product/group of products, ensuring International regulatory needs are incorporated into the development plan to ensure rapid market access with advantageous labelling.
  • Ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
  • Regional RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the company and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
  • Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. (GRL accountability in close collaboration with Regional RAD).
  • Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
  • Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
  • Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
  • Partners with marketing company staff to monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise regional and/or Global Product Teams (GPT) or ILT accordingly.
  • Partner with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.

Skills and Requirements:

  • Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interaction.
  • More than 5 years of experience or equivalent of regulatory drug development including product approval/launch.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
  • Demonstrated project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at + 203 078 9542 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.