Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?
Our Client a global leading Healthcare company is looking for a Senior Regulatory Affairs Manager
Tasks
* Support regulatory activities for products before and after launch.
* Keep records and databases organized and up to date.
* Make sure projects run smoothly and report progress to management.
* Join meetings for product launches, quality, and safety.
* Update technical files and review them regularly.
* Organize monthly calls with teams and share updates with management.
* Help with QA and safety matters and communicate clearly with the team.
* Manage 1-2 team members in the regulatory department.
* Attend training to improve skills.
* Respond to regulatory agencies on time.
Profile
* A degree in a relevant field, recognized in the EU, with experience in pharmaceutical regulations.
* At least 7 years of experience in the generic pharmaceutical industry.
* Good knowledge of how pharmaceutical products are developed.
* Experience working with different dosage forms like immediate, modified, and extended release.
* Familiar with ICH and regulatory guidelines.
* Comfortable using Microsoft Office and other basic IT tools.
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