Regulatory Affairs Analyst

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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 product information and review of artworks 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 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.

Qualifications

Educational qualification:

Minimum work experience:

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

Benefits Offered