Work as Subject Matter Expert - Drug Device Combination Products at Dr. Reddy's Laboratories

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.

Post : SME - Drug Device Combination Products

Job Description
Job summary
The Subject Matter Expert (SME) for Drug-Device Combination Products will serve as a key resource within the organization for technical expertise and regulatory guidance related to the development, manufacturing, and commercialization of drug-device combination products. This position will play a critical role in ensuring compliance with relevant regulations, standards, and best practices governing the design, development, and lifecycle management of combination products.

Roles & Responsibilities :
• In-depth knowledge of regulatory standards and guidelines governing drug-device combination products, including FDA regulations (e.g., 21 CFR 211, 21 CFR 820 & 21 CFR Part 4), EU Medical Device Regulation (MDR), and International Organization for Standardization (ISO 13485) standards.
• Experience with regulatory submissions and interactions with regulatory agencies (e.g., FDA, EMA, MHRA, ANVISA).
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels of the organization.
• Strong analytical and problem-solving skills, with a focus on attention to detail and accuracy.
• Provide technical guidance and support for the development, testing, and manufacturing of drug-device combination products, including, compatibility testing, stability studies, and manufacturing process validation and cleaning Validation.
• Provide training and education to internal stakeholders on relevant regulations, standards, and best practices for drug-device combination products.
• Stay abreast of emerging trends, regulations, and technologies related to drug-device combination products. Identify opportunities for process improvements and enhancements to streamline development and regulatory processes.
• Familiar with the various tools of investigation, able to resolve the problem
• Demonstrate expertise in conducting thorough investigations, root cause analysis, and provide the solution.

Candidate Profile
B.Pharmacy / M.Pharm / MSc Pharmaceutical Technology
Minimum 15 to 17 years of experience in the sterile formulation manufacturing & IPQA and medical device industry with specific expertise in drug-device combination products (DDCP).

Additional Information
Experience : 15 to 17 years
Qualification : B.Pharmacy / M.Pharm / MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 30th July 2024