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- Tasks: Lead regulatory strategies and manage submissions for global pharmaceutical products.
- Company: Join Novartis, a leader in innovative healthcare solutions dedicated to improving lives.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive team culture.
- Why this job: Be part of a passionate community making a real impact on patients' lives.
- Qualifications: Bachelor’s or Master’s in Life Sciences with significant regulatory affairs experience required.
- Other info: Commitment to diversity and inclusion is at the heart of our company values.
The predicted salary is between 43200 - 72000 £ per year.
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.
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?
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.
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry in both the UK and Ireland. Understanding the nuances of local regulations will help you demonstrate your expertise during interviews.
✨Tip Number 2
Network with professionals already working in regulatory affairs, especially those in senior roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss your experience with cross-functional teams and how you've successfully navigated complex regulatory projects. Be ready to provide examples that showcase your problem-solving and negotiation skills, as these are crucial for the role.
✨Tip Number 4
Research Novartis' recent initiatives and contributions to the pharmaceutical industry. Being knowledgeable about the company's values and goals will allow you to align your answers with their mission during the interview process.
We think you need these skills to ace Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Global Regulatory Affairs Associate Director position. Tailor your application to highlight relevant experience in regulatory affairs and project management.
Craft a Strong CV: Your CV should clearly outline your educational background, relevant work experience, and specific achievements in regulatory affairs. Use bullet points for clarity and ensure it reflects your ability to manage complex regulatory projects.
Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your skills align with the job description. Mention your experience with Health Authority interactions and your strategic input in regulatory plans to demonstrate your fit for the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks relevant to the pharmaceutical industry, especially those pertaining to the FDA and EMA. Being able to discuss these frameworks confidently will demonstrate your expertise and readiness for the role.
✨Showcase Project Management Skills
Prepare examples of past projects where you successfully managed regulatory submissions or negotiations. Highlight your ability to lead cross-functional teams and how you navigated challenges to achieve compliance and timely approvals.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving and negotiation skills. Think about specific instances where you had to influence Health Authority interactions or resolve regulatory issues, and be ready to discuss your approach.
✨Emphasise Communication and Collaboration
Since the role involves liaising with various stakeholders, emphasise your communication skills and experience in collaborative environments. Be prepared to discuss how you align regional regulatory strategies with global objectives and work effectively with diverse teams.
