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Senior Regulatory Affairs Director

Senior Regulatory Affairs Director

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Senior Regulatory Affairs Director

  • Location:

    Berkshire

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable depending on experience

  • Job type:

    Permanent - full time

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    SRA-KE_1719848086

  • Published:

    12 days ago

  • Duration:

    Permanent

  • Startdate:

    latest October 2024

We are seeking an experienced professional to join our client's team as the Senior Director of Regulatory Affairs for the Northern European Cluster and Regional Skin & Essential Health Franchise. Based in the South-East of England you will work in a Hybrid work environment. In this role, you will be at the forefront of regulatory strategy, guiding product registrations, line extensions and new indications to align with our client's business objectives. Your expertise will ensure compliance with relevant regulations and quality system requirements, driving operational excellence and strategic vision.

Key Responsibilities:

  • Leadership & Management: Oversee the Northern Europe Cluster & Regional Skin & Essential Health Franchise Regulatory Affairs team, managing the regulatory budget and fostering a culture of operational excellence.
  • Strategic Vision: Develop and implement product positioning strategies, providing critical regulatory insights to R&D and clinical leads.
  • Regulatory Expertise: Navigate and interpret regulatory landscapes to inform product positioning, competition, and risk management.
  • External Relationships: Represent a world-leading consumer health company with regulatory agencies and industry associations, maintaining and cultivating essential external relationships.
  • Regulatory Strategy: Lead the evaluation of risk and safety issues, recommend regulatory solutions, and oversee regulatory strategies to ensure compliance and protect corporate interests.
  • Compliance Oversight: Approve regulatory filing strategies, manage regulatory interactions, and adapt strategies based on legislative changes.
  • Advocacy & Innovation: Stay abreast of scientific and clinical advances, drive new regulatory approaches, and engage with stakeholders to shape science-based regulatory decision-making.

Qualifications:

  • Bachelor's degree or higher in a relevant field.
  • 10+ years of related regulatory experience.
  • Expertise across a broad spectrum of regulatory classifications, including medicinal products, cosmetics, commodities, and/or medical devices.
  • Solid understanding of regulatory, medical, safety, and quality requirements.
  • Proficiency in English.

Core competencies

  • Exceptional communication skills, both verbal and written.
  • Strong interpersonal skills with the ability to build effective networks.
  • Highly collaborative, with a keen sense of ownership and accountability.
  • Excellent organisational and analytical skills.
  • Ability to build and sustain partnerships across organisational boundaries.
  • Demonstrates sound judgement and develops creative solutions.
  • Ability to work effectively in a multicultural, highly matrixed organisation.

Why Join our client?

As a world-leading consumer health company, our client believes in creating a positive impact on health-care through innovative regulatory strategies and compliance excellence. As the Senior Director of Regulatory Affairs, you will have the opportunity to lead a talented team, influence key regulatory decisions, and shape the future of our products in the Northern European market. If you are a visionary leader with a passion for regulatory affairs and a commitment to excellence this could be the ideal role.

Please Send your latest resume and a cover letter outlining your experience and vision for the role or call me on 02079401985 if you require further information