National AI Awards 2025Discover AI's trailblazers! Join us to celebrate innovation and nominate industry leaders.

Nominate & Attend

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

Novartis
London
1 month ago
Create job alert

Job Description Summary
#LI-Hybrid (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.

Job Description

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

Skills Desired
#J-18808-Ljbffr

Related Jobs

View all jobs

Regulatory Consultant

Regional Regulatory Leader Seeds & Biotech, EMEA

Senior Manager, Regulatory Science Late-Stage Programs

Senior Manager, Global Regulatory Affairs

Commercial Regulatory Affairs Analyst

Associate Director, Clinical Operations

National AI Awards 2025

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

10 Biotechnology Recruitment Agencies in the UK You Should Know (2025 Job‑Seeker Guide)

The UK’s biotech boom—fueled by the £650 million Life Sciences Vision Fund and rapid mRNA, cell & gene‑therapy adoption—continues to outpace talent supply. Lightcast reported +45 % year‑on‑year growth in UK adverts mentioning “CRISPR”, “GMP bioprocess” or “cell therapy” during Q1 2025. Yet only about 25,000 specialised biotech professionals work nationwide, while monthly live vacancies average 1,800–2,100. All data verified 22 July 2025; re‑audit quarterly for freshness.. Specialist recruiters remain critical for tapping stealth roles, benchmarking salaries and streamlining the lab‑tour interview gauntlet. We reviewed 60 + consultancies and kept only agencies with: A registered UK head office (Companies House). A dedicated Biotechnology / Life‑Sciences practice. At least five UK biotech roles advertised between March and June 2025. Below you’ll find a hiring‑landscape snapshot, a quick directory of 10 vetted agencies, salary medians, in‑demand skills, interview expectations, FAQs and next steps—mirroring our AI and quantum guides.

Biotech Jobs Skills Radar 2026: Emerging Tools, Platforms & Technologies to Learn Now

The UK biotechnology sector is entering a new era—fuelled by AI integration, synthetic biology, and next-gen diagnostics. With biotech investment breaking records and a surge in demand for skilled talent across R&D, biomanufacturing, and regulatory fields, it’s vital for job seekers to future-proof their skillsets. Welcome to the Biotech Jobs Skills Radar 2026—a forward-looking guide to the emerging tools, lab techniques, platforms, and digital skills driving hiring in the UK's biotechnology industry. This radar is updated annually to help students, researchers, and transitioning professionals stay competitive in a fast-changing landscape.

How to Find Hidden Biotechnology Jobs in the UK Using Professional Bodies like the RSB, BIA, BioIndustry Association & More

The UK biotechnology sector is thriving. From cutting-edge gene therapies and synthetic biology to bio-manufacturing and agricultural innovation, the demand for skilled biotech professionals continues to grow. Yet many of the best opportunities—particularly in early-stage companies, startups, and research-intensive roles—are never listed on conventional job boards. So where do these hidden biotech jobs live? Often, they’re shared through word-of-mouth, member networks, or professional communities—especially those associated with leading biotech institutions and associations. Whether you’re a graduate looking for your first role, a research scientist ready to move into industry, or a regulatory professional seeking your next challenge, joining the right professional bodies can give you exclusive access to job leads, collaborations, and insider opportunities. In this article, we’ll show you how to strategically leverage UK-based organisations such as the Royal Society of Biology (RSB), BioIndustry Association (BIA), and Biotech and Life Sciences Networks to uncover hidden jobs and build a long-term, sustainable career in biotechnology.