▷ Urgent Search: Associate Director Regulatory Affairs

3 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview

Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.

Responsibilities

- Developing and implementing global regulatory strategies for assigned products.
- Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
- Providing input to submission strategy and other critical regulatory documents. May act as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
- May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
- Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
- Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
- Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Desirable experience/Qualifications

- Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
- Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
- Experience providing strategic regulatory advice for the global development of products through all stages of development including marketed assets.
- Successful track record in registering and overseeing regulatory strategies for assets.
- Bachelor’s Degree, life science highly desirable
- Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus

If this role is of interest, please apply now.

#LI-TE1

#J-18808-Ljbffr

  • Associate Director Regulatory Affairs

    4 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    OverviewAssociate Director Regulatory Affairs - Ireland, Dublin - 12 Month ContractAre you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation?We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.ResponsibilitiesDeveloping and implementing global...

  • Regulatory Affairs Associate

    2 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time Role Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals. We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets. As we expand our in-house capabilities, we are seeking a skilled...

  • Regulatory Affairs Associate

    3 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time RoleXeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals.We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets.As we expand our in-house capabilities, we are seeking a skilledRegulatory...

  • Senior Director of Regulatory Affairs

    3 weeks ago

    Dublin Pike, Ireland Panda International Full time

    Overview Director / Senior Director, Regulatory Affairs – Europe Location: Ireland (onsite presence required, hybrid flexibility) Therapeutic Area: Rare Diseases We are supporting a fast-growing biopharmaceutical company developing transformative therapies for rare diseases . With an established global operations and expanding European presence, the...

  • Director, Regulatory Affairs Cmc

    3 weeks ago

    Dublin, Ireland Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.As a leader in muscle biology and the mechanics of...

  • Director, Regulatory Affairs Cmc

    3 weeks ago

    Dublin, Ireland Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.As a leader in muscle biology and the mechanics of...

  • Senior Associate, Regulatory Affairs

    3 weeks ago

    Dublin, Ireland West Pharmaceutical Services, Inc Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Select how often (in days) to receive an alert:Title: Senior Associate, Regulatory AffairsRequisition ID: *****Date: Aug 11, ****Location:Dublin, Leinster, IEDepartment: Regulatory AffairsDescription:This is a hybrid position, 3 days a week onsite in our Dublin...

  • (High Salary) Director, Regulatory Affairs CMC

    4 weeks ago

    Dublin Pike, Ireland Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Fs Tax Directors

    3 weeks ago

    Dublin, Ireland Director File Full time

    We are working with the head of FS tax to help hire a Financial Services Tax Directors and Associate Directors to join their rapidly growing financial services tax team.Our client is the fastest growing firm in Ireland and has over **** people in 10 offices across Ireland, the Isle of Man, Gibraltar, and Bermuda, with a presence in over 130 countries around...

  • Regulatory Affairs Specialist

    2 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees.We develop and manufacture innovative patient friendly pharmaceutical products for international markets.We are now seeking an experienced Regulatory Affairs Specialist as we expand.Overall Role ObjectiveThe...