Company Overview: Zydus Lifesciences Ltd. has evolved from Cadila Healthcare Ltd., building on a legacy of over 70 years in healthcare. We are dedicated to improving lives through innovative solutions and a commitment to quality and compliance in our operations.
Position: Associate Manager / Manager – Regulatory Affairs
Location: Vadodara, Gujarat
Industry Type: Pharma/Healthcare/Clinical Research
Experience Required: 11 to 15 years
Application Deadline: 20th November 2024
Job Description: We are seeking a highly motivated and detail-oriented Associate Manager / Manager in Regulatory Affairs. The successful candidate will be responsible for:
- Preparing and reviewing high-quality Drug Master Files (DMF) and Certificates of Suitability (CEP) applications for Active Pharmaceutical Ingredients (APIs) to be submitted to regulatory authorities including the USFDA, European, and Rest of World agencies.
- Filing amendments and deficiency responses within established timelines, demonstrating a proactive approach.
- Conducting thorough document reviews against predefined checklists to ensure compliance prior to submissions.
- Maintaining and updating all regulatory databases to ensure accuracy and currency.
- Staying informed about regulatory guidelines and requirements globally, as well as emerging technical trends.
- Demonstrating a “do it right the first time” mentality with a proven track record of success.
- Exhibiting strong communication skills, professional email etiquette, and a consistent academic record of excellence.
- Possessing the energy and determination to navigate new and challenging situations effectively.
Qualifications:
- A strong background in regulatory affairs within the pharma or healthcare industry.
- Proven experience with DMF and CEP submissions to global regulatory agencies.
- Excellent organizational skills and attention to detail.
- Ability to work collaboratively in a fast-paced environment.
If you meet these qualifications and are ready to contribute to our mission of improving healthcare, we encourage you to apply.
How to Apply: Please submit your resume and a cover letter detailing your relevant experience and accomplishments.