Copy of SME - Regulatory Compliance

Roles & Responsibilities: 

• Strong understanding of regulatory requirements (e.g. USFDA EMA ICH EU GMP MHRA ANVISA ScheduleM WHO TGA Heath CANADA PDA & APIC) and quality management principles (e.g. GMP GLP ISO standards).
• Excellent written and verbal communication skills with the ability to draft clear and concise responses to regulatory findings.
• Evaluate regulatory guidelines and industry standards to assess their impact on current systems and business operations.
• Ability to work collaboratively in a crossfunctional team environment and manage multiple projects simultaneously
• Detailoriented approach with a focus on accuracy and compliance.
• Provide recommendations for aligning systems / procedures with updated guidelines and ensuring compliance with regulatory requirements.
• Stay abreast of changes in regulations and guidelines relevant to the organizations operations and incorporate them into procedure development.
• Work closely with subject matter experts department heads and quality assurance teams to gather input and feedback to strengthen the system/ procedure.
• Facilitate training sessions and workshops to ensure understanding and adherence to procedures across all levels of the organization.

Qualifications :

Educational Qualification

A Bachelors or Masters degree in Pharmacy Pharmaceutical Sciences Chemistry or a related field

Work Experience

1517 years of strong understanding of regulatory requirements regulatory response writing & communication.

Additional Information :

About the Department

Global Manufacturing Organization (GMO)

At Dr. Reddys 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 stateoftheart 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 1150 drug master files across key therapy areas such as Oncology Cardiovascular Central Nervous System and AntiDiabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.

Benefits Offered

At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

For more details please visit our career website at !/

Remote Work :

No

Employment Type :

Fulltime