Cadila Pharmaceuticals Limited: Hiring AGM/Manager – Regulatory Affairs (Formulation)
Summary:
Cadila Pharmaceuticals Limited, a leading research-driven pharmaceutical company in India, is seeking a highly motivated and experienced Regulatory Affairs professional to join our team as an AGM/Manager – Regulatory Affairs (Formulation) at our Dholka facility. This pivotal role offers an exceptional opportunity to lead and contribute to the regulatory strategy, submission management, and global compliance efforts for our formulation products. If you possess a strong background in regulatory documentation and a deep understanding of regulated and semi-regulated markets, we encourage you to apply and advance your career in pharmaceutical regulatory affairs with us.
About Cadila Pharmaceuticals Limited:
Cadila Pharmaceuticals Limited is committed to providing high-quality, affordable healthcare solutions globally. We are dedicated to innovation, research, and development, and our focus on excellence has made us a trusted name in the pharmaceutical industry. We offer a dynamic and challenging work environment where employees can grow and contribute to our mission of improving lives.
Job Title: AGM/Manager – Regulatory Affairs (Formulation)
Location: Dholka, India
Department: Regulatory Affairs
Job Overview:
The AGM/Manager – Regulatory Affairs (Formulation) will be a key leader in the Regulatory Affairs department, responsible for overseeing end-to-end regulatory activities related to formulation products. This includes dossier preparation, lifecycle management, and coordination with global regulatory agencies to ensure timely product approvals and compliance with international regulations. The successful candidate will possess a strong understanding of formulation development, regulatory pathways, and a proven track record of successfully navigating complex regulatory landscapes.
Key Responsibilities:
- Leadership: Lead the Regulatory Affairs – Formulation team, providing guidance and mentorship to team members for smooth operational execution and professional development.
- Dossier Preparation and Submission: Review, compile, and manage CTD/eCTD dossiers, technical documents, and product variation files for submission to regulatory agencies worldwide.
- Global Regulatory Compliance: Ensure compliance with global regulatory guidelines and requirements from authorities such as USFDA, EMA, MHRA, WHO, and other ROW (Rest of World) agencies.
- Cross-Functional Collaboration: Collaborate effectively with Formulation R&D, QA, QC, Packaging Development, and Manufacturing teams to ensure seamless integration of regulatory requirements into product development and manufacturing processes.
- Product Lifecycle Management: Manage product registration, renewals, updates, and responses to regulatory queries throughout the product lifecycle.
- Regulatory Intelligence: Monitor changes in international regulations and implement necessary updates to ensure continued compliance.
- Audit and Inspection Support: Support regulatory audits, inspections, and internal compliance initiatives, ensuring readiness and responsiveness to regulatory inquiries.
- New Product Launch Support: Ensure timely completion of regulatory submissions to facilitate successful new product launches.
- Team Management: Guide and mentor RA team members for smooth operational execution
Qualifications:
- Education: M.Pharm / M.Sc in Pharmaceutical Sciences or a related field.
- Experience: Minimum of 12 years of experience in Regulatory Affairs (Formulation) within the pharmaceutical industry.
- Technical Skills:
- In-depth understanding of formulation development, dossier preparation, and global regulatory pathways for pharmaceutical products.
- Proficiency in preparing and reviewing CTD/eCTD dossiers.
- Comprehensive knowledge of regulatory requirements and guidelines from various international regulatory agencies (e.g., USFDA, EMA, MHRA, WHO).
- Soft Skills:
- Excellent communication skills (both written and verbal).
- Strong documentation and organizational skills.
- Proven ability to coordinate effectively with cross-functional teams.
- Strong problem-solving and analytical skills.
- Leadership qualities and the ability to motivate and guide a team.
Benefits:
- Career Growth: Opportunity to work with one of India’s most reputable and trusted pharmaceutical companies, with ample opportunities for career advancement.
- Leadership Role: This is a leadership-level position with significant responsibility and the chance to shape the regulatory strategy for formulation products.
- Competitive Compensation: We offer a competitive compensation package commensurate with industry standards and experience.
- Global Exposure: Gain exposure to a wide range of global regulatory markets and contribute to the worldwide availability of our pharmaceutical products.
How to Apply:
Interested and qualified candidates are encouraged to apply by submitting their resume and cover letter to [email protected]. Please include “AGM/Manager – Regulatory Affairs (Formulation) Application” in the subject line.
We thank all applicants for their interest in Cadila Pharmaceuticals Limited. Only those selected for an interview will be contacted.