Date PostedApril 13, 2023
Experience8 Years, 13 Years
Desired QualificationBachelor Degree, Master’s Degree
Roles and Responsibilities:
Responsible for overseeing and ensuring compliance with all regulatory requirements for the development, approval, and marketing of pharmaceutical products.
- Develop and implement regulatory strategies: works closely with the research and development team to develop and implement regulatory strategies for the approval of new drugs.
- Ensure compliance with regulations: Ensures that the company is compliant with all applicable regulations and guidelines, including FDA regulations, international regulatory requirements.
- Coordinate and prepare regulatory submissions: Responsible for coordinating and preparing regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and other regulatory filings.
- Manage relationships with regulatory agencies: Establishes and maintains positive relationships with regulatory agencies.
- Stay up-to-date with regulatory changes: Stays up-to-date with changes to regulations and guidelines, ensuring that the company remains compliant and that its regulatory strategies are updated accordingly.
Required Candidate profile
- Should have experience in preparing and submitting regulatory dossiers, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
- Should have exceptional attention to detail and the ability to ensure the accuracy and completeness of regulatory dossiers.
- Should have strong project management skills and the ability to manage timelines and deliverables associated with the preparation and submission of regulatory dossiers.
- Should have excellent written and verbal communication skills and the ability to effectively communicate with internal and external stakeholders regarding regulatory dossier preparation and submission.
Qualification: B.Pharma, M.Pharma