Jobs

    Director Global Regulatory Affairs - Surrey, United Kingdom - EPM Scientific

    EPM Scientific
    EPM Scientific Surrey, United Kingdom

    2 days ago

    Default job background
    Description

    The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.

    DESCRIPTION OF THE ROLE


    • Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans and risk assessments and lead Health Authority interactions


    • Oversee, contribute to and/or prepare regulatory submissions.


    • Perform and prepare due diligence assessments that may include risk mitigation strategies.


    • Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities


    • Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance.


    • Manage the development of the ongoing global regulatory strategy.


    • Marketing access activities including pricing/contracts/product listings

    ESSENTIAL REQUIREMENTS FOR ROLE


    • Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline


    • 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry


    • Solid knowledge of FDA, EMA and other global regulations and ICH guidelines


    • Expert in product development and experience in early to late stage as well as post approval phases


    • Demonstrated experience in leading face-to-face meetings with FDA, EMA and/or other Health Authorities


    • Preparation of New Drug Applications and Marketing Authorisation Applications in eCTD format
    • Obtain Orphan Drug Designations in Europe and US


    • High level of personal integrity and ethical behaviour
    • Strong leadership and staff development skills

  • Apex International Recruitment

    Regulatory Affairs Associate

    1 day ago

    Apex International Recruitment Surrey, United Kingdom

    **Details**: · - Full-time permanent position · - Hybrid working - 3 days WFH, 2 days office (Surrey) · - Competitive package · - Global pharma company · **The Role**: · **Objective / Purpose of Role** · To support the Regulatory Affairs function of the Operations department, car ...

  • CY Partners

    Regulatory Affairs Safety and Compliance

    13 hours ago

    CY Partners Surrey, United Kingdom

    Are you a regulatory affairs professional looking for an exciting new role? · This role as Product Safety Compliance Officer will ensure that the company complies with all the applicable chemical regulatory requirements for products placed on the market. This role will also invol ...

  • EPM Scientific

    Regulatory Affairs Associate

    3 days ago

    EPM Scientific Surrey, United Kingdom

    Regulatory Affairs Associate · The Regulatory Affairs Associate will be responsible for: · • Managing the clinical trial applications in Europe and other selected countries · • Keeping up to date with regulatory and legal changes in EU · • Preparing pre- and post-authorisat ...

  • EPM Scientific

    Regulatory Affairs Associate

    4 days ago

    EPM Scientific Surrey, United Kingdom

    Job Description · Regulatory Affairs Associate · The Regulatory Affairs Associate will be responsible for: · • Managing the clinical trial applications in Europe and other selected countries · • Keeping up to date with regulatory and legal changes in EU · • Preparing pre- and po ...

  • EPM Scientific

    Director Global Regulatory Affairs

    4 days ago

    EPM Scientific Surrey, United Kingdom

    Job Description · The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. · DESCRIPTION OF ...

  • EPM Scientific

    Regulatory Associate

    3 days ago

    EPM Scientific Surrey, United Kingdom

    Regulatory Affairs Associate · The Regulatory Affairs Associate will be responsible for: · • Keeping up to date with regulatory and legal changes in EU · • Preparing pre- and post-authorisation regulatory documentation and applications · • Providing general regulatory advice ...

  • EPM Scientific

    Regulatory Associate

    6 days ago

    EPM Scientific Surrey, United Kingdom

    Job Description Regulatory Affairs Associate · The Regulatory Affairs Associate will be responsible for: · • Keeping up to date with regulatory and legal changes in EU · • Preparing pre- and post-authorisation regulatory documentation and applications · • Providing general re ...

  • EPM Scientific

    Regulatory Associate

    1 week ago

    EPM Scientific Surrey, United Kingdom

    Regulatory Affairs AssociateThe Regulatory Affairs Associate will be responsible for: · • Managing the clinical trial applications in Europe and other selected countries · • Keeping up to date with regulatory and legal changes in EU · • Preparing pre- and post-authorisation regu ...

  • EPM Scientific

    Director of Compliance

    3 days ago

    EPM Scientific Surrey, United Kingdom

    The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.DESCRIPTION OF THE ROLE · • Provide ...

  • Planet Pharma

    Human Resources Consultants

    6 days ago

    Planet Pharma Surrey, United Kingdom

    Job Title: People Operations Partner Location : 4 days at home, 1 day in office in Surrey · Contract Type: 6 Months with potential to extend · FTE: Full time 37.Planet Pharma are currently partnered with a global pharmaceutical company committed to improving the health of peopl ...

  • Planet Pharma

    Human Resources Consultants

    4 days ago

    Planet Pharma Surrey, United Kingdom

    Location : 4 days at home, 1 day in office in Surrey · Contract Type: 6 Months with potential to extend · FTE: Full time 37.Planet Pharma are currently partnered with a global pharmaceutical company committed to improving the health of people around the world through the provis ...

  • Colgate-Palmolive

    Professional Group Brand Manager NE

    5 days ago

    Colgate-Palmolive Surrey, United Kingdom

    No Relocation Assistance Offered · # Surrey, England, United Kingdom · Location: Guildford · Reporting to: Marketing Director, Toothpaste & Professional, NE Hub · Why Work For Colgate Palmolive: · The learning & development opportunities: You will refine your commercial mind-set ...

  • Cpl

    Patient Outcomes Assessment Director

    5 days ago

    Cpl Surrey, United Kingdom Freelance

    Title: Director, Patient-Centered Outcomes Assessment · Contract length: 12 months · Pay rate: £32.00 to £ 46.10 p/h (Can be flexible for right candidate) · Location: Tadworth, Hybrid · Role Summary · The Patient-Centered Outcomes Assessment (PCOA) Director will drive PCOA strate ...

  • Colgate-Palmolive Company

    Professional Group Brand Manager NE

    5 days ago

    Colgate-Palmolive Company Surrey, United Kingdom

    No Relocation Assistance Offered · # Surrey, England, United Kingdom · Who We Are · Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care an ...