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Director, Regulatory Affairs EU

4 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect life.

JOB SUMMARY

The Director, Regulatory Affairs will oversee regulatory activities across Emergent's product portfolio. The Director Regulatory Affairs is responsible for providing strategic direction to the business and other stakeholder functions as it pertains to EU & global licensure of Emergent products. The Director is responsible for leading the development and implementation of RA strategies and establishing optimal regulatory positions for all of Emergent's product portfolio and maintaining the licenses of existing commercial products.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Major Responsibilities and Duties
  1. Directs and develops regulatory group located across Emergent sites or remotely located.
  2. Develop and lead regulatory strategy, for the EU and global, for Emergent products.
  3. Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements.
  4. Direct efforts for planning and execution of required regulatory filings.
  5. Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  6. Prepare company team for EMA or and other health authority meetings.
  7. Serve as Regulatory Liaison to the EMA, MHRA, or local Member State Health Authorities in the EU (and other regulatory authorities) for assigned projects.
  8. Represent Regulatory Affairs at cross-functional teams core teams.
  9. Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches.
  10. Provide critical review of documentation supporting regulatory applications including, but not limited to, pre-IMPD and formal meetings with health authorities, IMPDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements.
  11. Ensure RA activities are aligned Project timelines & business objectives and are in compliance with ICH, FDA, HC, UK, and EU regulations.
  12. Maintain knowledge of regulatory environment, regulations and guidance.
  13. Interact with company partners and consultants for various regulatory matters as needed.
  14. Contribute regulatory perspective as needed on government proposals and external due diligence activities.
  15. Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs.
  16. Responsible for department budget.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  1. B.Sc. degree in related biological and life sciences field (M.Sc. or Ph.D. preferred).
  2. 12+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.
  3. Knowledge of EU and global regulations / guidance and thorough knowledge of biological/ drug development process required.
  4. Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
  5. Strong decision-making abilities.
  6. Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development.
  7. Possess a broad knowledge of biopharmaceutical manufacturing and operations.
  8. Demonstrated people-leader skills and evaluation of performance.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

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