Compliance and Quality Control Manager at MVM, Inc. Ensuring compliance with policies, laws, and internal standards while managing quality control operations.
About the role
- Regulatory Affairs Specialist supporting regulatory activities in the Gulf region for innovative pharmaceuticals. Ensuring compliance with regulations and collaborating cross-functionally.
Responsibilities
- Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.
- Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence).
- Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region.
- Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
- Responsible for ordering and legalization of local CPP and other module 1 documents for local products.
- Perform regulatory due diligence on module 1 for all assigned products for the Gulf.
- Ensure that the regulatory file is complete and available for dispatch to the distributor.
- Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers.
- Coordinate the responses to requests by the authorities during the evaluation process.
- Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
- Maintain the Regulatory databases: drug track and docubridge for local products.
- Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety.
Requirements
- Education in Pharmacy, Natural Sciences or relevant discipline.
- Minimum of 5 years’ experience working in the Pharmaceutical industry in Regulatory Affairs.
- Extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
- Proven ability to effectively work collaboratively in cross functional teams.
- Ability to work in a highly dynamic business environment.
- Cross-cultural awareness and ability to work across geographical markets.
- Multi-task ability and work well under pressure and tight deadlines.
Benefits
- N/A
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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