Regulatory Affairs Specialist

Job Summary

We are looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers ensuring compliance and timely approvals. This role is pivotal in managing activities pertaining to product lifecycle management quality management and pharmacovigilance including variations and renewals SOP development risk management and trainings. Collaboration with internal teams will be essential for supporting internal and external audits and implementing effective CAPA measures.

Roles & Responsibilities

• Dossier preparation including authoring review and finalization from the SRA approved BLA/MAA or authoring the dossier sections from the scratch including quality non-clinical and clinical sections from the technical reports for all novel products across regions as per country requirements.
• Uploading the country specific dossier in the SharePoint
• Preparation of responses to Query received from partner and MOH.
• Preparation of variation packages indication expansion package annual report as per country requirements
• Support in publishing of eCTD submissions and variation Packages.
• Due diligence for the in-licensed products for the DRL territory as per term sheet
• Filing regulatory applications (Licenses Toxicity studies clinical studies marketing authorizations compliance notifications).
• Co-ordination with CFTs for the in-licensed products like BD COE country team during submission and attending.
• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current pending and future approvals and renewals)
• Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements as well as monitor renewals to strict deadlines
• Act as liaison between multiple project partners to obtain significant information as well as answer queries that may arise
• Stay up to date with the latest rules and regulations
• Regulatory compliance and systems..

Qualifications :

Educational qualification: A  Master in Pharmacy or Master of Science or Industrial Pharmacy; Pharmacy professional license holder

Minimum work experience: 4 to 8 years of experience in regulatory affairs preferably with QA (Quality Assurance) and PV experience

Skills & attributes:

• Knowledge of FDA EMA/EM 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 :

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.

Diversity Equity & Inclusion

At Dr. Reddys we are deeply committed to building a diverse equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team.  We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

For more details please visit our career website at Work :

No

Employment Type :

Full-time