Director, Europe Regulatory Affairs Policy

1 week ago

Dublin, Dublin City, Ireland Allergan Full time
Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description
  • Location can be flexible across Europe
  • Reporting into the Head of Europe, Regulatory Policy & Intelligence

Position Overview:

The Director, Europe Regulatory Policy & Intelligence (RPI), will be a strong subject matter expert in regulatory policy and procedure, laws and regulations with a comprehensive understanding of how regulatory policy is shaped and developed within the European region. The Europe RPI Director will lead specified regulatory policy topics in a highly collaborative cross-functional environment and will work closely with counterparts from the US/C and Intercontinental areas. The role will address policy and intelligence gathering, analysis of changes in the regulatory environment and the impact of these changes to AbbVie, development of policy positions and advocacy strategies to advance policy goals through internal and external collaboration. The individual will work closely with RA and cross functional colleagues to coordinate policies to ensure alignment with AbbVie portfolio priorities.

The Europe RPI Director establishes, develops, and maintains relations with HAs, peer company contacts, and industry trade associations regarding scientific and regulatory policies. The role involves leadership of the development of cross-functional, multidisciplinary team responses to HA consultations. Through the provision of intelligence insights, the Director assists AbbVie to comply with scientific, ethical, statutory, quality, and business requirements.

Key Responsibilities:

  • Independently manages and leads global and/or regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives.
  • Serves as policy subject expert based on in depth knowledge of key regulatory and scientific issues. Analyzes proposed policies and distributes to SMEs. Leads formation of corporate position to share with trade associations.
  • Mentors junior staff in approaches to complex policy issues.
  • Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics.
  • Proposes sound regulatory policies influencing the regulatory environment in one or more geographic regions.
  • Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates consequences of path chosen.
  • Serves as liaison to trade associations for management on scientific and regulatory issues.
  • Supports supervisor and Senior Management in discussions of complex policy topics at trade associations.
  • Contributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment. May offer alternative views based on regulatory knowledge and prior experience.
Qualifications
  • Bachelor's degree related to health, environment or politics. Degrees in Pharmacy, Chemistry, Biology, Pharmacology or Law are most relevant.
  • Relevant Master's degree in a scientific, health, legal, or business discipline.
  • Policy experience is required either within the Pharmaceutical industry or a health authority.
  • Robust knowledge of healthcare regulations in support of drug development.
  • Proven leadership skills with strong managerial and research skills.
  • Experience working in a complex and matrix environment.
  • Strong communication skills, both oral and written.
  • Well-established regulatory network.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html


#J-18808-Ljbffr

  • Regulatory Affairs Professional

    54 minutes ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl Healthcare, a leading life sciences agency, seeks an experienced Regulatory Affairs Manager to join their team in Dublin.This full-time position reports directly to the Global Regulatory Affairs Associate Director and is responsible for managing operational registration and lifecycle management projects for company products.The successful candidate will...

  • Regulatory Affairs Director

    5 days ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Quanta Consultancy Services Ltd is a leading supplier of sterile injectable pharmaceutical products. Our research and development organization has a robust pipeline of products in development that we will bring to regulated and semi-regulated markets around the world.">">We are seeking an experienced Global Regulatory & Operations Lead to join our team in...

  • Director, Regulatory Affairs EU

    3 weeks ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    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,...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Senior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...

  • Policy Strategist

    6 days ago

    Dublin, Dublin City, Ireland Spencer Recruitment Full time

    At Spencer Recruitment, we are partnering with Liquid Gas Ireland (LGI) to find an experienced Policy Director who will lead advocacy, policy, and communications efforts at local, national, and European levels.LGI represents Ireland's LPG and BioLPG industry, advocating for cleaner and renewable energy solutions. As a member of Liquid Gas Europe, LGI is at...

  • Director, Regulatory Affairs EU

    2 weeks ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert: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...

  • Director, Regulatory Affairs EU

    4 weeks ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert: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...

  • Director, Regulatory Affairs EU

    3 weeks ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert: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...

  • Director, Regulatory Affairs EU

    2 weeks ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert: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...

  • Regulatory Affairs Director

    4 days ago

    Dublin, Dublin City, Ireland Gilligan Black Recruitment Full time

    Gilligan Black Recruitment is currently seeking an experienced Regulatory Affairs Director to join our team. In this key role, you will be responsible for ensuring the underwriting division's controls and governance framework are robust and aligned with regulations, reporting obligations, and company goals.Responsibilities:Ensure compliance with regulations...

  • Regulatory Affairs Expert

    4 days ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    Job Title: Regulatory Affairs ExpertCompany OverviewAt TN Ireland, we are a well-established international healthcare business with a significant presence in Ireland, the UK, and mainland Europe.We have a new opportunity for a Regulatory Affairs Expert to join our team in Tullamore, Co Offaly.

  • Head Of Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland Metamo Dac Full time

    About Us Progressive Credit Union is a not for profit, community-based credit union, dedicated to serving its 60,000 members with integrity and purpose.With an asset size in excess of €230 million, the credit union has seen significant growth in recent years across its seven-branch network located throughout the Leinster region.Due to this growth, the...

  • Director Regulatory Affairs

    3 days ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    Social network you want to login/join with:Director Regulatory Affairs - Device, DublinClient: The RFT GroupLocation: Dublin, IrelandJob Category: OtherEU work permit required: YesJob Reference: 8f16f2ec00f7Job Views: 110Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Senior Director Device Regulatory AffairsThis is a rare opportunity to join a...

  • Public Affairs Lead

    5 days ago

    Dublin, Dublin City, Ireland Spencer Recruitment Full time

    Spencer Recruitment is working with Liquid Gas Ireland (LGI) to find an experienced Policy Director who will lead advocacy, policy, and communications efforts at local, national, and European levels.LGI represents Ireland's LPG and BioLPG industry, advocating for cleaner and renewable energy solutions. As a member of Liquid Gas Europe, LGI is at the...

  • Head Of Regulatory Affairs

    20 hours ago

    Dublin, Dublin City, Ireland Metamo Dac Full time

    About Us Progressive Credit Union is a not for profit, community-based credit union, dedicated to serving its 60,000 members with integrity and purpose.With an asset size in excess of €230 million, the credit union has seen significant growth in recent years across its seven-branch network located throughout the Leinster region.Due to this growth, the...

  • Regulatory Affairs Director

    13 hours ago

    Dublin, Dublin City, Ireland Metamo Dac Full time

    About Progressive Credit Union">We are a community-based credit union, dedicated to serving our members with integrity and purpose.Our growth has been significant, with an asset size in excess of €230 million. Our seven-branch network spans the Leinster region.To meet our existing and future needs, we invite applications for a full-time, permanent Head of...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...

  • Regulatory Affairs and Compliance Director

    10 hours ago

    Dublin, Dublin City, Ireland Hudson River Trading Full time

    Hudson River Trading requires an experienced Regulatory Affairs and Compliance Director to oversee the Compliance program, ensuring the firm meets its responsibilities.Responsibilities Include:Oversee compliance risk assessments and monitoring, reporting findings and implementing changes.Routinely review regulatory inquiries, ensure well-written and...

  • Director Regulatory Affairs

    4 weeks ago

    Dublin, Dublin City, Ireland The RFT Group Full time

    Job Description Senior Director Device Regulatory Affairs This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. 2023 has been a year of highly...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...