Dr. Reddy Hiring Pharmacy Graduates | Regulatory Affairs Role – Apply
A Regulatory Affairs Job opportunity is available at Dr. Reddy’s Lab, specializing in biologics and biosimilars registration across Emerging Markets, including the Middle East and LATAM. This role demands expertise in regulatory submissions and compliance, with a focus on timely approvals and collaboration with health authorities.
About The Company
Dr. Reddy’s Lab is a prominent organization in the pharmaceutical sector, dedicated to the development and commercialization of innovative therapies. With a focus on biologics and biosimilars, Dr. Reddy’s Lab operates in various global markets, striving to meet the evolving healthcare needs of patients and healthcare providers.
Regulatory Affairs Job Description
In this regulatory affairs role, the candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for Biosimilars in Emerging Markets.
- Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, LATAM, and Africa.
- Support product registrations, renewals & variations.
- Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management.
- Respond to health authority queries in coordination with CMC, clinical, and quality teams.
- Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
- Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc.
- Familiarity with GCC-CTD and regional WHO biosimilar guidelines.
- Experience working with local affiliates or partner companies in Emerging Markets.
- Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc.
- Experience with regional electronic submission platforms.
Eligibility Criteria
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
- Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
- Knowledge of CTD structure, Module 1 customization, and regional submission formats.
- Strong project management, communication, and stakeholder coordination skills.
Why This Role?
This position provides an opportunity for Regulatory Affairs professionals to work on global biologics and biosimilars registrations across multiple Emerging Markets. The role offers exposure to different regulatory pathways, health authorities, regional submission requirements and cross-functional coordination with CMC, clinical and quality teams.
This Regulatory Affairs Job opportunity at Dr. Reddy’s Lab is ideal for qualified candidates seeking to advance their careers within the dynamic field of biologics and biosimilars. Interested individuals are encouraged to apply before the deadline to be considered for this pivotal role.
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