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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 mission-driven team that makes a real impact on patients' lives.
- Qualifications: Bachelor’s or Master’s in Life Sciences with significant regulatory affairs experience required.
- Other info: Fluency in English is essential; commitment to diversity and inclusion is valued.
The predicted salary is between 72000 - 108000 £ 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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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.
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) employer: Job Traffic
Contact Detail:
Job Traffic 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 through platforms like LinkedIn or industry-specific events. Building connections can provide insights into the role and may even lead to referrals, increasing your chances of landing the job.
✨Tip Number 3
Prepare for potential interview questions by practising your responses to scenarios involving regulatory challenges. Highlight your problem-solving skills and experience in managing complex projects, as these are crucial for the role.
✨Tip Number 4
Showcase your ability to work cross-functionally by discussing past experiences where you collaborated with different teams. This is essential for the role, as it involves aligning regional regulatory approaches with global objectives.
We think you need these skills to ace Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly within the pharmaceutical industry. Emphasise your project management skills and any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and how your background fits the requirements. Mention your experience with Health Authority interactions and your strategic input in regulatory plans.
Highlight Key Skills: In your application, focus on key skills such as negotiation, problem-solving, and communication. Provide examples of how you've successfully managed complex regulatory projects and collaborated with cross-functional teams.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A well-presented application reflects attention to detail, which is crucial for a role in regulatory affairs.
How to prepare for a job interview at Job Traffic
✨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 of specific instances where you had to manage risks or resolve conflicts with health authorities, and be ready to discuss your approach and outcomes.
✨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 have effectively communicated complex regulatory information to diverse teams.
