Pakistan Job Openings
Pharmatec Pakistan (Pvt.) Limited
Regulatory Affairs Manager (Male)
Karāchi
FULL TIME
September 19, 2024
The ideal candidate must be having:
Minimum 5-7 Years of experience of working in similar role in pharmaceutical company.
Male candidates are encouraged to apply.
The position needs to be filled on priority.
The company offer market competitive compensation & benefits
Key Responsibilities:
- Lead regulatory strategy development and execution for drug development projects, including pre-IND meetings, IND submissions, and NDA/BLA filings.
Prepare and submit regulatory documents, including new drug applications (NDAs), biologics license applications (BLAs), and amendments.
Act as a liaison with regulatory agencies to facilitate communication and resolve issues.
Monitor and interpret regulatory guidelines and updates, ensuring compliance with evolving regulations.
Collaborate with cross-functional teams, including clinical, quality, and manufacturing, to support regulatory submissions and compliance.
Develop and implement regulatory strategies to support product lifecycle management, including labeling and advertising. Conduct regulatory impact assessments and provide recommendations to senior management.
Maintain accurate and up-to-date records of regulatory submissions and communications.
Job Type: Full-time
Application Deadline: 30/09/2024
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