Regulatory Affairs Drug Manager

Regulatory Affairs Drug Manager

verifiedwork outline icon8 - 12 Years of Experiencerupess outline icon10.00L - 11.00L  Per Annumtime outline iconFull Time

Nishita Placement And Securities

time outline iconBari Brahmana, Jammu and Kashmir, India

Posted on 20-11-2023

267 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.