Regulatory Affairs specialist

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job summary
We are looking for an individual to carry out core regulatory science related activities, including dossier drafting and finalization, scientific advice and/or briefing book documents, filing regulatory applications, internal liaison for regulatory information compilation, coordination with Quality Assurance teams during audits, and ensuring regulatory compliance and systems.

Roles & Responsibilities

Candidate should have hands on experience in (1) drafting dossiers, (2) Scientific advice package, in particular the CMC and NC sections for regulated markets.

Candidate should have in-depth experience of Module 3 and part of module 2, in lines with CTD expectations for India, EM and HRM markets.

Candidate should be involved in preparation of applications and packages for various biologics/biosimilars regulatory submissions.;

Candidate should review primary documents (as appropriate) for submissions and ensure compliance with regulations and guidance.

Candidate should be well versed with relevant guidance’s applicable for CMC package requirements for (1) new submissions and (2) post approval changes.  

Updating and maintaining regulatory databases and ensure regulatory compliance; Familiar/Hands on with regulatory submission software’s including eCTD, SPL, etc.

Candidate will be well versed with assessment of the Change Controls against variation guidelines and preparation of country specific variation packages

Candidate should support in preparing, reviewing and submitting renewal documents/ renewal dossiers/ PAC’s/support in responding to queries raised by Health Agencies.

Educational qualification and Work experience:

Either  

(1) Master’s degree in any of the life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, regulatory affairs, pharmacy etc.); with minimal 8-10 years’ industrial experience in the area of biosimilars/biologicals-CMC related activities. Prior experience in Regulatory dossier drafting will be an advantage;

OR

(2) Phd in Biological science subjects, with minimal 1-3 years’ experience in scientific and/or regulatory dossier writings

Behavioral skills
• Possesses strong negotiation skills, cultural sensitivity, and excellent interpersonal skills.
• Pays meticulous attention to details in tasks and responsibilities.
• Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health (MOH).
• Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.