Director of Regulatory Strategy

3 days ago

Cork, Cork, Ireland Life Science Recruitment Full time
Job Overview

Life Science Recruitment is currently recruiting for a highly skilled Associate Director - Clinical Regulatory Scientist to join their team on a permanent basis.

This role offers the opportunity to develop and execute regulatory strategies for the US and Canadian markets, working closely with cross-functional teams to deliver integrated regulatory solutions.


Key Responsibilities:

Develop and update US and Canada registration strategies, leveraging scientific, drug/device clinical development, and knowledge from FDA/HC meetings and regulatory trends.

Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organization and knowledge of competitor labelling.

Monitor upcoming and recent approvals of competitive development programs/plans.

Integrate US/CA regulatory strategy into global registration strategy.

Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.

Communicate and share key information to enable seamless execution of US/Canada regulatory strategy.

Provide input to clinical program to support market differentiation needs.

Communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment.

Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.

Collaborate with internal teams for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning.

Support development and update of labelling strategy to deliver market differentiation.

Initiate and update Claims Mapping, and Labelling Dashboard.

Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources.

Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.

Use global labelling strategy to influence the drug development strategy.

Create and communicate labelling dashboard to drive internal alignment on labelling strategy and key risks.

Develop and Update US and CA labelling, including prescribing information, patient labelling, device labelling (IFU) for new products and indications.

Support the development of the US/Canadian labelling strategy in collaboration with Senior Regulatory Scientist and project personnel.

Support strategic development of US/CA labelling documents for initial submission, line extensions, key changes, and key updates, and provide responses to agency labelling questions.

Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo.

Determine and communicate submission and approval requirements and regulator expectations.

Generate regulatory documents for submissions.

Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate the organization's scientific position.

Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team.

Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.

Liaise with product and clinical development team and liaison with diagnostic development experts.

Provide high-quality, timely, and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development.

Communicate regulatory risks, potential impact, and mitigation plans with development team leadership and regulatory management.

Cultivate relationships with development teams.


Requirements:

Bachelor's degree in scientific or health sciences discipline.

Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years.

Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable.

Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required.

Demonstrated ability to assess and manage risk in a highly regulated environment.

Demonstrated strong written, spoken, and presentation communication.

Demonstrated negotiation and influence skills.

Demonstrated attention to detail.

Demonstrated effective teamwork skills; able to adapt to diverse interpersonal skills.

  • Director of Regulatory Strategy

    1 day ago

    Cork, Cork, Ireland Eli Lilly and Company Full time

    We are seeking a highly experienced Director of Regulatory Strategy to join our team and lead the development and implementation of regulatory strategies that drive business success. The successful candidate will have a strong background in regulatory affairs, with experience in developing and executing regulatory strategies for pharmaceutical products.The...

  • Director of Regulatory Strategy

    4 hours ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    About the RoleWe are looking for a highly skilled and experienced Director of Regulatory Strategy to lead our regulatory affairs team in Eli Lilly Cork. In this role, you will be responsible for developing and executing strategic plans to achieve business objectives, ensuring compliance with regulatory requirements, and building strong relationships with...

  • Medical Director

    3 days ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    About the Role:We are seeking a highly experienced Medical Director to lead our regulatory strategy for the US and Canadian market.As a key member of our team, you will develop and execute the regulatory strategy for new products and indications, ensuring compliance with FDA and Health Canada regulations.This is an excellent opportunity to join a leading...

  • Director of Regulatory Operations

    23 hours ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    LIFE SCIENCE RECRUITMENT LTD seeks a Director of Regulatory Operations to lead our regulatory operations team. As a senior member of our team, you will be responsible for developing and executing the regulatory strategy for the US and Canadian market.The Director of Regulatory Operations will oversee the development, update, and execution of US and Canada...

  • Director of Regulatory Affairs

    1 day ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    OverviewEli Lilly And Company is a global healthcare leader committed to making life better for people around the world. Our mission is to unite caring with discovery, and we strive to deliver innovative solutions that improve human health.We are seeking an experienced Director of Regulatory Affairs to join our team. As a key member of our regulatory...

  • Director of Regulatory Operations

    3 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Job Description:A key role has arisen for a Regulatory Affairs Director to join our client's Global Business Centre. The successful candidate will be responsible for leading the development and maintenance of global labeling, including core labeling documents related to drug, device, CMC, and carton/container components.The purpose of this role is to provide...

  • Regulatory Affairs Director

    5 days ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    About the RoleWe are seeking a highly skilled and experienced Associate Director to join our Explor&D Regulatory Affairs team. As a key member of the team, you will be responsible for providing strategic, tactical, and operational direction and support to deliver global regulatory strategies from candidate selection to clinical proof of concept for assigned...

  • Associate Director of Regulatory Operations

    2 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    LIFE SCIENCE RECRUITMENT seeks a seasoned Associate Director of Regulatory Operations. As an Associate Director - Global Core Labeling, you will lead the development and maintenance of global labeling for our clients.Your key responsibilities will include providing leadership for the development of global labeling strategy, implementing 'Accelerate Reach and...

  • Director of Clinical Regulatory Affairs

    3 days ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    About the Role:We are seeking a skilled Director of Clinical Regulatory Affairs to lead our regulatory strategy for the US and Canadian market.As a key member of our team, you will develop and execute the regulatory strategy for new products and indications, ensuring compliance with FDA and Health Canada regulations.This is an excellent opportunity to join a...

  • Associate Director of Regulatory Excellence

    3 days ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    Job DescriptionThe Associate Director of Regional Regulatory Scientist provides strategic leadership and technical expertise to ensure regulatory compliance and excellence across the organization. This role requires collaboration with cross-functional teams, including molecule development, quality assurance, and compliance.Key responsibilities include...

  • Associate Director, Regulatory Excellence

    5 days ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    About the OpportunityWe are seeking an exceptional Associate Director to lead our Explor&D Regulatory Affairs team. This is a unique opportunity to join a dynamic and innovative organization that is shaping the future of healthcare.The successful candidate will be responsible for developing and implementing global regulatory strategies, collaborating with...

  • Clinical Regulatory Strategy Manager

    1 day ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    We are looking for a Clinical Regulatory Strategy Manager to join our team at Life Science Recruitment Ltd. As a key member of our regulatory team, you will be responsible for developing and executing the regulatory strategy for the US and Canadian market.The Clinical Regulatory Strategy Manager will develop, update, and execute US and Canada registration...

  • Regulatory Strategy Lead

    1 day ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    Key ResponsibilitiesThe successful candidate will have a strong background in regulatory affairs and drug development, with a minimum of 5-8 years of industry experience. Key responsibilities will include:1. Developing and implementing regulatory strategies that align with business objectives2. Collaborating with cross-functional teams to ensure regulatory...

  • Associate Director Global Regulatory Affairs

    2 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Associate Director Global Regulatory AffairsAssociate Director Global Regulatory AffairsOur client, a global pharma company, is currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.Responsibilities:People...

  • Associate Director Global Regulatory Affairs

    7 days ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a...

  • Associate Director Global Regulatory Affairs

    1 day ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis.People management experience is essential for this role.This role offers hybrid working.Responsibilities: People Management: Recruit, develop, and retain a...

  • Associate Director of Regulatory Affairs

    2 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    About the Role:We are seeking an experienced Associate Director of Regulatory Affairs to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.The successful candidate will be responsible for ensuring timely delivery of global labeling to our clients...

  • Head of Core Labeling Strategy

    1 day ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    Purpose of the Associate Director/Director RoleThe purpose of the Associate Director/Director, Global Regulatory Affairs (GRA) Global Core Labeling (P4/P4-2) role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.This role ensures timely delivery...

  • Director of Engineering Strategy

    2 days ago

    Cork, Cork, Ireland Pm Group Full time

    Pm Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process.We value the contributions of all our people and respect individual differences.About Us:Pm Group is a global leader in engineering, architecture,...

  • Clinical Regulatory Lead

    3 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    This role presents an exciting opportunity for a highly motivated and experienced Clinical Regulatory Scientist to take on a leadership position within our client's team. As Associate Director - Clinical Regulatory Scientist, you will be responsible for developing and executing regulatory strategies for the US and Canadian markets, working closely with...