Regulatory Affairs Professional with Lifecycle Expertise

1 day ago


Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist to serve as an expert individual contributor within our organization. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage and execute highly complex or specialized projects. The Specialist will apply advanced regulatory expertise, adapting precedents and developing innovative approaches to ensure compliance and successful product approvals.

Main Responsibilities:

- Lead the development and preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.

- Act as the primary liaison with regulatory agencies to expedite approval of pending registrations and maintain compliance throughout the product lifecycle.

- Provide regulatory guidance during product planning and implementation, regulatory strategy development, risk management, and chemistry manufacturing control (CMC) activities.

- Ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.

- Represent the regulatory function in cross-functional teams, including marketing, research, and technical groups.

- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory requirements.

Required Skills & Qualifications:

- Excellent understanding of regulatory guidelines and processes.

- Strong project management and problem-solving skills.

- Effective communication and stakeholder management abilities.

- Ability to work independently as a subject matter expert and contribute to cross-functional teams.

About Us:

This is a fantastic opportunity to join a dynamic team and be a part of shaping the future of our industry. As a key member of our team, you will have the chance to make a real impact and contribute to the success of our organization.

What We Offer:

- Opportunity to work with a talented team of professionals

- Comprehensive training and development program

- Collaborative and dynamic work environment

How to Apply:

Please submit your resume and cover letter to us through our website. We look forward to hearing from you



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