Regulatory Affairs Specialist

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 new application submissions for Europe through DCP, MRP, NP. Collaboration with European Regulatory authorities and internal teams will be essential to ensure the regulatory compliance for new applications.

Roles & Responsibilities

• Should have an regulatory experience in Europe market new application submissions
• Preparation, review and submission of new applications through DCP, MRP, NP for EU.
• You will be responsible for preparation and review of m1 documentation in-line to the m2-5 documents.
• You will be responsible for preparation of artworks, including product information to ensure regulatory compliance.
• Direct Interaction with EU regulatory authorities.
• Handling of deficiencies and timely response to regulatory agencies
• Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
• Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
• Support the manufacturing sites during Regulatory audits
• You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
• You will be responsible for preparation and submission of the regulatory dossiers to Europe.
• You will be responsible for preparation and review of m1 documentation in-line to the m2-5 documents.
• You will be responsible for preparation of artworks, including product information to ensure regulatory compliance.
• You will be responsible for delivering registration goals with minimum supervision.
• You will be responsible for monitoring and follow-up of product filings for early approval of applications with regulatory authorities.
• You will be responsible for participating in the industry association to keep abreast of regulations.
• You will be responsible for creation and revision of new or existing SOPs (Standard Operating Procedures).
• You will be responsible for developing and maintaining a good relationship with the Europe health authorities.
• You will be responsible for performing other tasks and duties assigned by the immediate supervisor.

Educational qualification: M.SC or M.pharm

Minimum work experience: 8 to 12 years of experience in regulatory affairs preferably in Europe registrations (Including M1)

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.

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/#!/