Regulatory Affair Analyst

Job Summary
We are seeking for a detailoriented Regulatory Affair analyst  to join our team in Hyderabad India. In this role you will play a crucial part in ensuring our organizations compliance with regulatory requirements and strategies.

Roles & Responsibilities

• Prepare  regulatory dossiers for submissions for pharmaceutical or medical device products for CN and TW Mkts
• Implement regulatory guidelines and requirements to ensure compliance during New Product development /Leverage Filing Approval and Launch
• Assist in the development and implementation of regulatory strategies for new and existing products
• Connect and Collaborate with CFTs including manufacturing sites / CMOs / ILOS partners reviewing the various plant documents coordinating with Country team for dossier preparation clarifications 
• Listing the open points during filing and ensuring the responses are made ready before deficiency is received
• Understanding the deficiency and preparation of deficiency response by coordinating with CFTs in time
• Understand and interpret changes /new guidances that evolve at CDE and evaluate the impact on existing or upcoming products pipeline Communicate the updates to relevant stakeholders
• Coordinating with the NPL  team and identifying the right time for variation filing to ensure that the supplies would not get disturbed
• Maintain accurate and appropriate archival of regulatory information through databases and Documentation
• Participate in regulatory agency inspections and audits as needed
• Contribute to the continuous improvement of regulatory processes and procedures

Qualifications :

• Qualification : M Pharm ; Years of Experience : 4 to 6 years
  Mandatory Skills : Knowledge on Pharmaceutical Development Development ; FDA NMPA and EMA guidelines Good Communication Skills (Written Oral and Presentation)
• Proficiency in regulatory documentation and technical writing
• Understanding of compliance management principles
• Proficient in Microsoft Office Suite and regulatory information management systems
• Ability to work effectively in a fastpaced dynamic environment
• Willingness to travel occasionally for regulatory inspections or meetings/Training programs 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

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