Sme- Drug Device Combination Products
3 months ago
**Company Description**
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 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.
**Qualifications**
B Pharmacy / M Pharm / M S c 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** About the Department**
**Global Manufacturing Organisation (GMO)**
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug m
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SME- Drug Device Combination Products
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