Regulatory Affairs Drug Manager
Nishita Placement And Securities
Bari Brahmana, Jammu and Kashmir, India
Posted on 20-11-2023
314 Views
3 Vacancies
Description
Job Role:
- Ensuring that all products meet the regulatory requirements and standards set by health authorities.
- Overseeing the preparation, review, and submission of regulatory documents for new drug applications, clinical trial applications, marketing authorization, and variations to ensure accuracy and completeness.
- Acting as a point of contact for regulatory agencies, maintaining relationships with them, and representing the company in discussions, meetings, and negotiations with these authorities.
- Formulating regulatory strategies for product development and approval, providing input into the planning and execution of these strategies in alignment with business goals.
- Assessing and mitigating risks associated with regulatory compliance, anticipating regulatory obstacles, and devising solutions to ensure timely product approvals.
- Working closely with various departments such as R&D, clinical, quality assurance, legal, and marketing to ensure regulatory considerations are integrated into all aspects of the product life cycle.
- Adherence to Quality Standards.
- Labeling and Packaging Compliance.
- Post-Market Surveillance.
Category
Regulatory Affairs / Pharmacovigilance
Preferred Education
BPharm (Bachelor Of Pharmacy)
Key Skills
Communication SkillsRegulatory Affairs Drug ManagerRegulatory AffairsTeam Work
Benefits
- PF, Yearly Increment.
Contact Info
Address:
Bari Brahmana, Jammu and Kashmir, India