Senior Leader Regulatory Strategy Development

23 hours ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000
Job Title: Associate Director Regulatory Affairs

The position of Associate Director Regulatory Affairs involves overseeing the development and implementation of global regulatory strategies for assigned products. This role requires expertise in drug development and regulatory policy, as well as strong scientific and business judgment.

About the Role

This position is responsible for providing strategic regulatory advice for the global development of products through all stages of development, including marketed assets. The successful candidate will have a proven track record in registering and overseeing regulatory strategies for assets.

Key Responsibilities
  • Developing and implementing global regulatory strategies for assigned products
  • Providing regulatory strategic oversight for projects in relevant therapeutic areas/portfolio, aligned to overall Enterprise objectives
  • Acting as the point of contact with relevant Health Authorities and/or leading interactions with such authorities or other external stakeholders
  • Providing input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise
  • Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders
Requirements

The ideal candidate will have extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies. A Bachelor's Degree in a life science is highly desirable, and postgraduate degrees relevant to the role are a plus.

Benefits

This role offers the opportunity to work in a dynamic and innovative environment, driving continuous improvement and excellence in Regulatory Affairs. The successful candidate will be part of a collaborative team that prioritizes knowledge sharing, innovation, and professional growth.

  • Director of Human Resources and Development

    2 weeks ago

    Dublin, Dublin City, Ireland Health Products Regulatory Authority Full time

    Director of Human Resources and DevelopmentDirector of Human Resources and DevelopmentBrightwater Executive is delighted to be retained exclusively by our client, the Health Products Regulatory Authority (HPRA) in their search for a Director of Human Resources and Development.About the CompanyThe Health Products Regulatory Authority (HPRA) is the independent...

  • Director Of Human Resources And Development

    1 week ago

    Dublin, Dublin City, Ireland Health Products Regulatory Authority Full time

    Director of Human Resources and DevelopmentDirector of Human Resources and DevelopmentBrightwater Executive is delighted to be retained exclusively by our client, the Health Products Regulatory Authority (HPRA) in their search for a Director of Human Resources and Development.About the CompanyThe Health Products Regulatory Authority (HPRA) is the independent...

  • Financial Strategy Leader

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDirector Full time €112,974 - €139,320

    Job SummaryThe Health Products Regulatory Authority (HPRA) seeks a seasoned Director of Finance, Legal and Corporate Affairs to join its leadership team. As a key member, you will play a pivotal role in shaping the organisation's financial, legal and corporate strategy.Key ResponsibilitiesEnsure compliance with regulatory requirements and organisational...

  • Director of Strategy

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeLeadership Full time €60,000 - €80,000

    Senior Leadership PositionAs a key member of the senior leadership team, you will play a pivotal role in shaping and delivering organisational strategy. You will collaborate closely with the CEO and senior executives to strengthen leadership and drive effective financial and operational planning.Main ResponsibilitiesCollaborate with the CEO and senior...

  • Data Strategy Associate Director

    2 weeks ago

    Dublin, Dublin City, Ireland PLACE Strategy GmbH Full time

    When you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential.We are known as an organisation that encourages you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only through the...

  • Regulatory Strategies Research Lead

    1 day ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time

    Regulatory Strategies Research Lead – MedTech and Connected Health AccelerationThis role is pivotal in driving the success of a collaborative initiative to advance research commercialisation of novel healthtech innovations. We seek an experienced professional with a deep understanding of medtech and connected health regulatory landscapes and associated...

  • Urgent Search) Data Strategy Associate Director

    2 hours ago

    Dublin, Dublin City, Ireland PLACE Strategy GmbH Full time

    When you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential.We are known as an organisation that encourages you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only through the...

  • Women's Rugby Strategy Leader

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeRugby Full time €60,000 - €80,000

    Women's Rugby Strategy LeaderWe are seeking a seasoned leader to drive the growth of women and girl's rugby.About the RoleThis is a 4-year fixed-term contract based between our Dublin Head Office and High Performance Centre in Dublin.Coordinate and lead the overall women's game strategy.Shape and deliver the women and girls' rugby strategy.Work directly with...

  • Strategic Regulatory Affairs Leader

    1 day ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time

    We are seeking a visionary Senior Regulatory Affairs Director to lead our Global Regulatory Affairs team.The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry and a proven track record in project management and regulatory operations.They will be responsible for directing the development and submission...

  • Digital Strategy Leader

    23 hours ago

    Dublin, Dublin City, Ireland beBeeProductivity Full time €80,000 - €100,000

    Senior Digital Product StrategistThe key to success lies in innovation, speed of execution, and agility. A company that celebrates people who make smart choices is seeking a skilled professional.This individual will be accountable for developing and delivering a 3-5 year product strategy and roadmap, encompassing planning, execution, technology, customer,...