Pakistan Job Openings

Pharmatec Pakistan (Pvt.) Limited

AM/DM Regulatory Officers

Karāchi

FULL TIME

September 9, 2024

•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

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