Global Regulatory Affairs Associate Director

2 weeks ago

Dublin, Dublin City, Ireland Novartis Ireland Full time
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)

Join to apply for the Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) role at Novartis Ireland

Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)

4 days ago Be among the first 25 applicants

Join to apply for the Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) role at Novartis Ireland

Get AI-powered advice on this job and more exclusive features.

Summary

(3 days per week on-site)

Location: London (The Westworks), United Kingdom or Dublin, Ireland

Internal Job Title: Senior Global Program Regulatory Manager

We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle.

About The Role

Major accountabilities:

  • Lead the implementation of regulatory strategies and operational activities across major global regions.
  • Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
  • Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
  • Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.
  • Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
  • Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.
  • Develop and implement strategies to minimize review delays and regulatory clock stops.
  • Ensure timely and compliant responses to HA queries and requests.
  • Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
  • Ensure adherence to internal policies, SOPs, and global regulatory requirements.

Minimum Requirements
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
  • Significant experience in regulatory affairs within the pharmaceutical industry.
  • Proven track record in project management and regulatory operations.
  • Experience representing the organization in cross-functional and cross-cultural settings.
  • Strong knowledge of clinical trials, drug development, and regulatory compliance.
  • Excellent problem-solving, negotiation, and communication skills.
  • Detail-oriented with the ability to manage complex regulatory projects.
  • Skilled in risk management and working with cross-functional teams.
  • Ability to navigate and influence Health Authority interactions.
  • Fluency in English (written and spoken) is essential.

Commitment to Diversity and Inclusion/EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join Our Novartis Network

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits And Rewards

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Seniority level
  • Seniority levelDirector
Employment type
  • Employment typeFull-time
Job function
  • Job functionLegal
  • IndustriesPharmaceutical Manufacturing

Referrals increase your chances of interviewing at Novartis Ireland by 2x

Sign in to set job alerts for "Director Global Regulatory Affairs" roles.

Dublin, County Dublin, Ireland 2 weeks ago

Global Head of Regulatory Affairs, Pharmaceuticals

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 1 week ago

Senior Director / Regulatory Affairs Head EU

Dublin, County Dublin, Ireland 4 hours ago

Global Regulatory Affairs Director (Global Program Regulatory Director)

Dublin, County Dublin, Ireland 4 days ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

  • Associate Director Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland Pe Global Full time

    2 days ago Be among the first 25 applicants Direct message the job poster from PE Global Senior Recruitment Consultant @ PE Global Description: PE Global is currently recruiting for a Regulatory Affairs Associate Director on behalf of a leading pharma company based in Dublin South.This is an initial contract role until the end of 2025.Position Summary: The...

  • Associate Director Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland PE Global Full time

    2 days ago Be among the first 25 applicantsDirect message the job poster from PE GlobalSenior Recruitment Consultant @ PE GlobalDescription:PE Global is currently recruiting for a Regulatory Affairs Associate Director on behalf of a leading pharma company based in Dublin South. This is an initial contract role until the end of 2025.Position Summary:The...

  • Global Regulatory Affairs Associate Director

    1 week ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Join to apply for the Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) role at Novartis Ireland Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) 4 days ago Be among the first 25 applicants Join...

  • Global Regulatory Affairs Director

    2 weeks ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    Global Regulatory Affairs Director (Global Program Regulatory Director) Join to apply for the Global Regulatory Affairs Director (Global Program Regulatory Director) role at Novartis Ireland Global Regulatory Affairs Director (Global Program Regulatory Director) 4 days ago Be among the first 25 applicants Join to apply for the Global Regulatory Affairs...

  • Global Regulatory Affairs Director

    9 hours ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    Global Regulatory Affairs Director (Global Program Regulatory Director)Join to apply for the Global Regulatory Affairs Director (Global Program Regulatory Director) role at Novartis Ireland Global Regulatory Affairs Director (Global Program Regulatory Director)4 days ago Be among the first 25 applicants Join to apply for the Global Regulatory Affairs...

  • Global Regulatory Affairs Director

    2 weeks ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    Global Regulatory Affairs Director (Global Program Regulatory Director)Join to apply for the Global Regulatory Affairs Director (Global Program Regulatory Director) role at Novartis IrelandGlobal Regulatory Affairs Director (Global Program Regulatory Director)4 days ago Be among the first 25 applicantsJoin to apply for the Global Regulatory Affairs Director...

  • Associate Director Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    1 week ago Be among the first 25 applicants Direct message the job poster from Tandem Project Management Ltd. Senior Talent Solutions Specialist at Tandem | ERF Certified Recruiter Summary: An Associate Regulatory Affairs Director is required for a biopharmaceutical company in West Dublin.The role involves leading global regulatory strategies for assigned...

  • Associate Director Regulatory Affairs

    4 weeks ago

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

    Associate 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 aAssociate Director Regulatory Affairs to support the Dublin function.Essential duties and responsibilities for this role...

  • Associate Director Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    1 week ago Be among the first 25 applicantsDirect message the job poster from Tandem Project Management Ltd.Senior Talent Solutions Specialist at Tandem | ERF Certified RecruiterSummary:An Associate Regulatory Affairs Director is required for a biopharmaceutical company in West Dublin. The role involves leading global regulatory strategies for assigned...

  • Associate Regulatory Affairs Director

    2 weeks ago

    Dublin, Dublin City, Ireland Lsc, Life Science Consultants Full time

    Associate Regulatory Affairs Director (BBBH28356) Dublin, Republic of Ireland LSC have a great contract opportunity for an Associate Regulatory Affairs Director to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming...