Regulatory Associate at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Assurance, Pharmacovigilance, SOP Development, Risk Management, Training, FDA Guidelines, EMA Guidelines, Interpersonal Skills, Communication Skills, Attention to Detail, Multi-tasking, Deadline Management, English Proficiency, Computer Proficiency, Google Applications, MS Excel

Industry

Pharmaceutical Manufacturing

Description

Company Description Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because 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. Job Description I’m 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. 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. Job Family: Regulatory Affairs Sub Job Family: Regulatory Affairs General Preferred type of working: On-Premise Years of Experience: 3 - 6 Business unit: Biologics

Responsibilities

The Regulatory Associate will oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals. This role involves managing product lifecycle activities, quality management, and pharmacovigilance.