Novartis is a global healthcare company that focuses on innovative medicines, eye care, and generics. With a strong commitment to improving global healthcare and addressing unmet medical needs, Novartis offers transformative solutions for patients. The company strives to maintain a patient-centered approach in all its endeavors, ensuring regulatory compliance and high-quality standards in every aspect of its operations. Novartis’s diverse portfolio includes products in a wide range of therapeutic areas, including oncology, ophthalmology, neuroscience, and immunology. With operations spanning across many countries, Novartis is at the forefront of medical advancements, utilizing cutting-edge technology and innovative solutions to improve the quality of life for millions worldwide.
Responsibilities in the Job:
As a Regulatory Affairs Specialist at Novartis India, your role will be pivotal in managing regulatory documentation and submissions. Key responsibilities include:
- Managing Regulatory Submission Projects: Handle medium to small-level global regulatory submission projects ensuring compliance with all necessary regulatory requirements.
- Documentation Management: Ensure a controlled documentation system, including both technical and non-technical documentation, with adherence to regulatory standards.
- Collaboration and Communication: Act as a liaison between various internal teams and external regulatory bodies. Communicate submission components, documentation standards, and ensure regulatory dossiers are assembled efficiently.
- Submission Strategy Contribution: Contribute to regulatory strategies and intelligence to develop, register, and maintain global products.
- Reporting and Compliance: Ensure that technical complaints, adverse events, and special cases related to Novartis products are reported within 24 hours. Adhere to Novartis policies and guidelines throughout.
- Continuous Learning: Stay updated on product information and engage in continuous collaboration with regional and divisional customers.
- Project Management: Utilize strong project management skills to oversee regulatory submission processes while managing resources, timelines, and risk.
Qualifications:
To be considered for the Regulatory Affairs Specialist role, candidates must meet the following qualifications:
- Educational Background: A degree in Life Sciences, Pharmacy, or a related field is required.
- Professional Experience: Minimum 2-3 years of experience in Regulatory Affairs or a related field with expertise in documentation management and regulatory compliance.
- Cross-Cultural Experience: Familiarity with working in a multicultural environment and understanding diverse regulatory frameworks.
- Communication Skills: Strong written and verbal communication skills in English, as effective documentation and stakeholder interactions are essential.
- Experience in Global Submissions: Prior involvement in regulatory submissions for global product registration is highly advantageous.
Skills:
- Regulatory Compliance: Expertise in regulatory frameworks, submission standards, and maintaining compliance with local and global regulations.
- Documentation Management: Strong skills in managing both technical and non-technical documentation, including quality control and ensuring compliance with regulatory requirements.
- Data Analysis: Proficiency in data analysis and extracting pertinent information for submission processes and reports.
- Project Management: Ability to oversee multiple projects and work with cross-functional teams to meet deadlines and achieve regulatory goals.
- Operational Excellence: High attention to detail with operational excellence in documentation management and regulatory processes.
- Clinical Study Reports: Experience in the preparation and submission of clinical study reports as part of regulatory submissions.
- Lifesciences Knowledge: A solid understanding of life sciences, particularly in pharmaceutical or biotech sectors, is essential.
How to Apply:
To apply for the Regulatory Affairs Specialist position at Novartis India, please follow these steps:
- Visit the Novartis career portal or job listing website where the position is advertised (e.g., LinkedIn, Novartis official site).
- Create an account or log in to your existing profile.
- Navigate to the job ID REQ-10039385 for the Regulatory Affairs Specialist role.
- Upload your updated resume and cover letter, making sure to highlight your experience in regulatory affairs, documentation management, and relevant skills.
- Submit your application and await further instructions regarding the interview process.
