Regulatory Affairs Analyst

We are looking for a Regulatory Affairs Specialist Global Lifecycle Management (LCM) to support and manage postapproval regulatory activities across global markets ensuring compliance and timely maintenance of product licenses.

This role is pivotal in managing activities related to global lifecycle submissions including variations renewals label updates artwork changes CMC updates site transfers and administrative maintenance. Collaboration with global Health Authorities manufacturing sites and internal crossfunctional teams will be essential to ensure continuous regulatory compliance of marketed products.

Roles & Responsibilities

• Should have regulatory experience in lifecycle management activities for multiple markets especially in Europe
• Preparation review and submission of variations (Type IA/IB/II) renewals notifications and administrative updates for global markets including EU UK and RoW markets etc.
• You will be responsible for preparation and review of Module 1 and CMC variation documentation
• You will be responsible for preparation of product information updates (SmPC PIL labels) and review of artworks to ensure regulatory compliance.
• Direct interaction with global regulatory authorities (EU NCAs MHRA other countries health authorities officials as applicable).
• Handling of postapproval deficiencies/queries and providing timely responses to regulatory agencies.
• Good interpersonal skills with strong command of English to communicate with regulatory authorities & IL customers/partners.
• Providing regulatory guidance and regulatory strategies to CMOs and other crossfunctional teams for postapproval changes.
• Support manufacturing sites during regulatory audits inspections and compliancerelated queries.
• You will be responsible for monitoring and followup of product lifecycle submissions for early and timely approvals.
• You will be responsible for updating and maintaining regulatory databases tracking tools and submission logs.
• You will be responsible for participating in industry associations to keep abreast of global postapproval regulatory requirements.
• You will be responsible for creation and revision of new or existing SOPs related to lifecycle management.
• You will be responsible for maintaining strong relationships with global health authorities and regulatory stakeholders.
• You will be responsible for delivering lifecycle management goals with minimum supervision.
• You will be responsible for performing other tasks and duties assigned by the immediate supervisor.

Qualifications :

Educational qualification: or

Minimum work experience: 8 to 12 years of experience in regulatory affairs preferably in Europe Lifecycle management activities 

Skills & attributes:

• Knowledge of EMA guidelines.
• Proficiency in spoken and written English.
• Proficiency in using a computer and its applications specifically Google Applications and MS Excel.
• Excellent interpersonal and communication skills.
• Attention to detail and the ability to multi-task and meet strict deadlines.

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused 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 :

Full-time