Are you looking for a fulfilling career in regulatory affairs within the pharmaceutical industry? Novartis, a global leader in innovative medicines, is hiring a Regulatory Affairs (RA) Site Head for its India operations in Mumbai. If you have a passion for enhancing patient care through strategic regulatory management and possess extensive experience in drug development and registration, this position might be the perfect fit for you.
About Novartis and the Role
Novartis boasts one of the most dynamic product pipelines in the pharmaceutical sector today, driven by a commitment to research and development and a diverse workforce dedicated to performance excellence. As the Regulatory Affairs Site Head in India, you will play an integral role in shaping the regulatory strategy for key product registrations and lifecycle management activities, working closely with cross-functional teams to achieve ambitious business goals.
Key Responsibilities
As the Regulatory Affairs Site Head, your major activities will include:
- Strategic Leadership: Designing and executing the strategic vision for RA in India in alignment with regional and global objectives.
- Budget Management: Overseeing the RA budget to ensure efficient use of resources to meet set targets.
- Product Registration: Establishing product development and registration objectives, ensuring adherence to regulatory requirements while accelerating priority products through innovative filing approaches.
- Team Leadership: Directing the regulatory affairs team in preparing high-quality documentation for Health Authorities such as the DCGI and State FDA.
- External Relations: Building and maintaining robust relationships with key Health Authority decision-makers and participating in significant industry forums.
- Functional Excellence: Driving the implementation of regulatory compliance processes and functional excellence initiatives to support Novartis’s portfolio across India.
Candidate Profile
To excel in this role, candidates should meet the following qualifications:
- Educational Background: A Master’s degree in Life Sciences is required, with a PhD or higher degree considered an asset.
- Experience: A minimum of 15 years in drug development and registration, showcasing a proven track record of successful health authority negotiations.
- Language Proficiency: Fluent in English, with strong communication capabilities.
- Cross-Functional Collaboration: Ability to work effectively in a cross-functional and cross-country environment, managing diverse products within Novartis’s portfolio.
Why Join Novartis?
At Novartis, you will be part of an innovative culture that prizes collaborative teamwork, continuous learning, and professional growth. You will have the opportunity to influence regulatory strategy that directly impacts patient access to groundbreaking therapies. As an employer, Novartis values diversity and seeks to foster an inclusive environment where every individual can thrive.
Key Performance Indicators
Success in this position will be measured against various performance metrics, such as:
- Recognition among internal stakeholders as a reliable partner in driving regulatory strategy.
- Achievement of multiple registration milestones and timely market launches with competitive labeling.
- Effective communication regarding regulatory changes and their impact on the business.
- Successful implementation and sustainability of regulatory excellence across the portfolio.
Apply Now
If you are ready for a new challenge and meet the qualifications for this exciting position, consider joining Novartis as the Regulatory Affairs Site Head in India. This is an opportunity to make a significant impact in the pharmaceutical industry while advancing your career in a global organization.
Job ID: REQ-10025796
Location: Mumbai (Head Office)
Application Deadline: 28th February 2025
