Regulatory Associate
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Job Location:
Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Im 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
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About Company
Dr. Reddys 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 Cant Wa ... View more
