Associate Regulatory Affairs -External Manufacturing (Nag)

3-6 years

Not Disclosed

Hyderabad

10 Aug. 14, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Dr. Reddy’s Laboratories Ltd. is a global leader in the pharmaceutical industry, committed to delivering affordable and innovative medicines across the world. With a workforce of over 24,000 dedicated employees, we are united by a singular purpose: to accelerate access to quality healthcare, because Good Health Can’t Wait.

Founded in 1984 with just 20 employees and a bold vision, Dr. Reddy's has grown into a multinational presence with research and development centers, manufacturing facilities, and commercial operations in 66 countries. Over the past four decades, we have built a strong reputation for access, affordability, and innovation, all grounded in deep scientific expertise, progressive people practices, and robust corporate governance. As the pharmaceutical landscape evolves, we embrace the opportunity to strengthen our core operations while pioneering new initiatives for the future.

Our strategy, "The Next and the New," reflects our commitment to being a purpose-driven, future-ready, and sustainable partner of choice. By 2030, we aim to reach over 1.5 billion patients worldwide by expanding our core businesses and driving future growth, with sustainability at the heart of our mission. For us, sustainability means operating in a way that respects people, the planet, and our purpose—conserving resources, serving patients, creating value for stakeholders, contributing to society, and upholding our integrity and transparency.

At Dr. Reddy’s, we are committed to fostering a diverse and inclusive work environment. We are an equal-opportunity employer, dedicated to hiring and nurturing a talented workforce without regard to race, color, religion, nationality, gender, age, disability, sexual orientation, gender expression, citizenship, or any other characteristic protected by applicable laws. We value merit and diversity and recognize the unique contributions of every individual in our organization.

Job Description

We are seeking a highly motivated individual to join our regulatory affairs team. This role involves managing core regulatory activities, including authoring, compiling, and publishing regulatory submissions, as well as supporting lifecycle management for externally manufactured products (both Dr. Reddy’s and in-licensed products) to ensure regulatory compliance and system integrity.

Responsibilities:

Author, compile, and publish regulatory submissions, including chemistry, manufacturing, and controls (CMC) supplements, new drug applications, and generic drugs.
Provide regulatory operational support for External Manufacturing operations, including coordination with Contract Manufacturing Organizations (CMOs), obtaining necessary documentation, managing change controls, and reviewing master documents.
Compile post-approval changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs managed by North America Generics (NAG).
Author annual reports for drug products and ensure timely submission.
Assemble and maintain regulatory files, including FDA communications.
Provide regulatory input and support for cross-functional teams working with external products.
Monitor and track upcoming supplements and annual reports.
Offer routine operational support to NAG External Manufacturing for in-licensed and out-licensed products.
Prepare regulatory strategy notes, support regulatory due diligence, and assist with product launches in consultation with the team lead.
Participate in the digitalization of external products.
Provide publishing support to the team as needed.
Manage all GDUFA-related submissions, including fees, establishment registrations, self-identification, and annual volume reporting.

Qualifications:

Education: Bachelor’s or Master’s degree in life sciences; RAC certification is highly desired.
Experience: A minimum of 4-6 years of experience in the generic pharmaceutical industry, including 3-6 years in regulatory affairs.

Skills & Attributes:

Technical Skills: Hands-on experience with CMC submissions, labeling activities, and product launches; solid understanding of 21 CFR regulations and global regulatory guidelines.
Behavioral Skills: Strong communication and interpersonal skills; attention to detail; ability to work effectively with cross-functional teams and CMOs; commitment to continuous learning and staying updated on regulatory expectations; ensure appropriate maintenance of regulatory documentation.

Additional Information

Benefits:

At Dr. Reddy’s, we are committed to your professional growth and development, offering personalized learning programs. Our benefits package is among the best in the industry, including relocation support, family support (maternity and paternity benefits), medical coverage for you and your family, and life insurance.

Work Culture:

At Dr. Reddy’s, our guiding principle is that Good Health Can’t Wait. We view healthcare solutions not just as scientific formulations, but as a means to help people lead healthier lives. Our work culture is rooted in empathy and dynamism, with a focus on teamwork and shared success. We believe that diverse skills, bound by a common purpose and value system, can achieve extraordinary results.

For more details, please visit our career website at Dr. Reddy's Careers.

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Associate Regulatory Affairs -External Manufacturing (Nag)

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