[WORK FROM HOME] Genedrift is Hiring for Regulatory Affairs Job

Genedrift, a leading provider of regulatory and pharmacovigilance solutions in the life sciences industry, is expanding its team and inviting applications for positions in Regulatory Affairs. With a focus on innovation and compliance, Genedrift offers a dynamic work environment where professionals can contribute to groundbreaking therapies in pharmaceuticals, biologics, and medical devices.

If you have a passion for regulatory compliance, dossier management, and collaborating with health authorities, this role could be the perfect step in your career. Genedrift is committed to inventing and reinventing solutions that drive the pharma sector forward.

Key Roles and Responsibilities

As a Regulatory Affairs professional at Genedrift, you will play a crucial role in ensuring seamless regulatory processes. Key responsibilities include:

• CTD/ACTD/Non-CTD dossier review and compilation (covering CMC, SmPC, PI, PIL, and labelling)
• Gap analysis and Health Authority (HA) query/deficiency management
• Pre-submission and post-submission support with Health Authorities
• Ensuring regulatory compliance, documentation control, and data security
• Cross-functional collaboration to achieve timely submissions and enhance client satisfaction

These duties demand attention to detail, strong analytical skills, and the ability to work in a fast-paced environment focused on quality and timelines.

Required Qualifications and Experience

To excel in this role, candidates should meet the following criteria:

• Education: B.Pharm or M.Pharm
• Experience: 2-5 years in regulatory affairs, preferably with exposure to biologics, biosimilars, injectables, vaccines, and medical devices
• Strong knowledge of regulatory guidelines and dossier preparation
• Excellent communication and teamwork skills

Candidates with hands-on experience in international regulatory submissions will have an added advantage.

Salary, Benefits, and How to Apply

Genedrift offers a competitive salary package in the range of INR 5-9 Lakhs per annum, depending on experience, skills, and qualifications. In addition to an attractive compensation structure, employees benefit from opportunities for professional growth, a supportive work culture, and the chance to work on innovative projects in the pharma regulatory space.

How to Apply: Interested candidates are encouraged to apply immediately via the official careers page: genedrift.com/openings. Submit your updated resume along with a cover letter highlighting your relevant experience.

Don’t miss this opportunity to advance your career with a forward-thinking organization like Genedrift!

Application Link