Regulatory Affairs Analyst

Job Description

We are looking for a Regulatory Affairs Specialist – Global Lifecycle Management (LCM) to support and manage post‑approval 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 cross‑functional 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 post‑approval 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 CMO's and other cross‑functional teams for post‑approval changes.
• Support manufacturing sites during regulatory audits, inspections, and compliance‑related queries.
• You will be responsible for monitoring and follow‑up 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 post‑approval 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: M.pharm

Minimum work experience: 4 plus 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 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/