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

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

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.
  
  

• 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.
  
  

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Novartis by 2x

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

International Regulatory Affairs Director (International Program Regulatory Director)

London, England, United Kingdom 2 weeks ago

Executive Director, Global Regulatory Affairs, Head of European Local Operating Companies and Regional Reliance Lead

London, England, United Kingdom 1 week ago

London, England, United Kingdom 1 month ago

U.K./European Regulatory Affairs Director

London, England, United Kingdom 2 weeks ago

Legal Director, Head of Regulatory Affairs

Greater London, England, United Kingdom 2 days ago

Associate Director of Global Regulatory Affairs

London, England, United Kingdom 1 week ago

Director of Legal and Regulatory Affairs (Permanent)

London, England, United Kingdom 3 weeks ago

Executive Director Legal - Global Regulatory Law

London, England, United Kingdom 2 weeks ago

Associate Director Regulatory Affairs Innovative Medicine

Director, Safety Surveillance & Risk Management (Pharmacovigilance Department)

Hatfield, England, United Kingdom 6 days ago

QARA Customer Operations Manager (12 MTHS Maternity Cover)

Little Chalfont, England, United Kingdom 3 weeks ago

Hatfield, England, United Kingdom 2 days ago

Regulatory Affairs Manager – Oncology Cell Therapy

Uxbridge, England, United Kingdom 1 month ago

Senior Principal, Regulatory Affairs - Companion Diagnostics

Amersham, England, United Kingdom 2 weeks ago

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