Join a Leading Pharmaceutical Innovator as a Regulatory Affairs Executive
An exciting opportunity has arisen for a highly motivated and skilled Regulatory Affairs Executive to become a vital part of a dynamic pharmaceutical company. This role is instrumental in upholding the highest standards of global regulatory compliance, ensuring the successful delivery of quality healthcare products to markets worldwide.
We are seeking a professional with 2-3 years of dedicated experience in regulatory affairs within the pharmaceutical sector. Candidates must possess a Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) degree, demonstrating a solid academic foundation in the field.
The position is based at our Head Office, conveniently located at 5/2 Industrial Area, Kirti Nagar, New Delhi – 110015.
Key Responsibilities for this Role:
The Regulatory Affairs Executive will undertake a broad spectrum of crucial tasks, including:
- Dossier Management: Meticulously preparing and reviewing comprehensive regulatory dossiers and submissions.
- Stakeholder Coordination: Acting as a key liaison, coordinating effectively with both regulatory authorities and external clients.
- Documentation & Compliance: Compiling and maintaining essential product registration documents, ensuring their accuracy and accessibility.
- Lifecycle Management: Proficiently handling variations, renewals, and all other pertinent regulatory compliance activities throughout a product’s lifecycle.
- Material Review: Conducting thorough reviews of packaging materials, labels, and artwork to guarantee strict adherence to regulatory guidelines.
- Knowledge Upkeep: Proactively staying updated with the latest regulatory guidelines, requirements, and industry best practices.
Desired Skills and Attributes:
Successful applicants will be distinguished by:
- A profound and robust knowledge of pharmaceutical regulatory requirements.
- Practical experience in dossier preparation, with a preference for familiarity with CTD/eCTD formats.
- Exceptional documentation capabilities and strong verbal and written communication skills.
- An unwavering attention to detail coupled with a proactive, regulatory compliance-focused mindset.
This role offers a unique chance to contribute significantly to a company dedicated to advancing healthcare through stringent regulatory adherence. We encourage qualified individuals to explore this opportunity to help us uphold our commitment to excellence.
A detailed visual representation of this career opening is available.
