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- Tasks: Lead regulatory strategies and submissions for global pharmaceutical products.
- Company: Join Novartis, a diverse and inclusive leader in the pharmaceutical industry.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive community.
- Why this job: Make a real impact on patients' lives while collaborating with passionate professionals.
- Qualifications: Bachelor's or Master's in Life Sciences; significant regulatory affairs experience required.
- Other info: Fluency in English is essential; commitment to diversity and inclusion is a must.
The predicted salary is between 43200 - 72000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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.
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) employer: Novartis
Contact Detail:
Novartis 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 latest regulatory guidelines and frameworks relevant to the pharmaceutical industry. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in regulatory affairs, especially those who have experience with global regulatory strategies. Engaging in discussions or attending industry events can provide insights and connections that may give you an edge in the application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated complex regulatory challenges in your previous roles. Highlighting your problem-solving skills and ability to manage cross-functional teams will resonate well with the hiring managers.
✨Tip Number 4
Research Novartis' recent projects and initiatives in regulatory affairs. Being able to reference their work during your conversations will show your genuine interest in the company and its mission, making you a more appealing candidate.
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: Thoroughly read the job description for the Global Regulatory Affairs Associate Director position. Make sure you understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your significant experience in regulatory affairs within the pharmaceutical industry. Provide specific examples of projects you've managed that align with the role's requirements.
Showcase Your Skills: Demonstrate your problem-solving, negotiation, and communication skills in your application. Use concrete examples to illustrate how you've successfully navigated complex regulatory projects or influenced Health Authority interactions.
Tailor Your Application: Customise your CV and cover letter to reflect the values and culture of Novartis. Mention your commitment to diversity and inclusion, as well as your passion for helping patients, which aligns with their mission.
How to prepare for a job interview at Novartis
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to the pharmaceutical industry. Familiarise yourself with the specific regulations from agencies like the FDA and EMA, as this knowledge will be crucial during your discussions.
✨Showcase Your Project Management Skills
Be prepared to discuss your experience in managing complex regulatory projects. Highlight specific examples where you successfully led initiatives, navigated challenges, and achieved compliance within tight deadlines.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with cross-functional teams, share examples of how you've effectively collaborated with different departments. Emphasise your ability to align regional regulatory approaches with global objectives.
✨Prepare for Health Authority Interactions
Anticipate questions about your experience with Health Authority interactions. Prepare to discuss strategies you've implemented for successful negotiations and how you've handled queries or requests from regulatory bodies.
