RA Specialist
Share
Job Location:
Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Job Summary
Regulatory Affairs Specialist will 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
- Preparation and submission of the regulatory dossier.
- Delivering registration goals with minimum supervision.
- Monitoring and follow-up of product filings for early approval of applications.
- Revision of artworks including prescribing information to ensure regulatory compliance.
- Product lifecycle management including variations renewals and post-approval commitments.
- Participating in the industry association to keep abreast of regulations.
- Creation and revision of new or existing SOPs (Standard Operating Procedures).
- Management of quality activities including product release handling complaints deviations self-inspection of change controls trainings documentations and risk management.
- Management of PV (Pharmacovigilance) activities such as adverse event monitoring.
- Audit of third-party distributors.
- Supporting internal and external audits and implementation of CAPA (Corrective and Preventive Actions).
- Developing and maintaining a good internal and external network.
- Performing other tasks and duties assigned by the immediate supervisor.
Qualifications :
Qualifications Experience Skills & Attributes
Educational qualification: A Bachelor of Science in Pharmacy or Industrial Pharmacy; Pharmacy professional license holder
Minimum work experience: 1 to 3 years of experience in regulatory affairs preferably with QA (Quality Assurance) and PV experience
Skills & attributes:
- Knowledge of FDA 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
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
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
