Regulatory Affairs Associate

Prepare and compile regulatory documentation, including dossiers, submissions

Analyze and interpret regulatory guidelines, requirements, and industry standards to ensure organizational compliance

Support the preparation and submission of regulatory applications to relevant authorities

Conduct regulatory research and gap analysis as per Regulatory requirements and guidelines

Collaborate with cross-functional teams including quality assurance, product development, and operations to gather necessary information for regulatory submissions

Monitor changes in regulatory requirements and communicate updates to relevant stakeholders

Assist in authoring dossier sections, query responses, variation applications

Maintain knowledge of current Good Pharmaceutical Practices (GPR) and ensure adherence across assigned projects

Support the organization's regulatory compliance program through documentation, tracking, and reporting

Regulatory Life cycle management

Educational qualification: A Master’s degree in any of the life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, regulatory affairs, pharmacy etc.)

Minimum work experience: 3-5 years of experience in Biologics Regulatory Affairs; Any additional experience in biologics/biosimilar research and development, process & analytical development is good to have

Skills & attributes:

Technical Skills

Ability to stay up-to-date with business priorities and a skill to calibrate strategies against the changing dynamics of the business environment.

Good understanding of Information Technology (IT) platforms supporting regulatory activities, including eCTD publishing, DMS, and Regulatory  Information Management System (RIMS).

Knack for analysing regulatory information to identify risks, demonstrating the ability to assess regulatory data critically and identify potential challenges or areas of concern.

Excellent verbal, written, communication and interpersonal skills; Sound logical and analytical attributes; Good understanding of CMC, NC and Clinical aspects of a Regulatory dossier

Sound knowledge of ICH/LATAM guidelines on submission requirements and understanding of global regulatory affairs

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.

With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.

With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.

Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.

We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure

Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/