Ruhsatlandırma Uzmanı

Job description

Details:
• Develop best regulatory strategies: continuous analysis of risks and opportunities for new assets requires close follow up of the internal and external trends and strategic planning from early development through launch
• Planning and execution of post-approval submissions (renewals, technical variations, new indication, label updates) and conduct effective cross-functional interactions to preserve business continuity
• Follow up of developments and changes in the local & global regulations and analyzing the potential impact on the registrations
• Interaction with Agency members and external stakeholders
• Lead GMP related tasks including inspections which require close follow up with internal and external stakeholders
• Act as a key role at brand teams (contains multiple functions) to provide regulatory input/advice
• Ensure timely regulatory submissions and approvals of new Marketing Authorisation applications & GMP dossiers
• Lead strong relationships with internal and external stakeholders
• Ensure the organization's regulatory activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
• University degree in related fields (such as Faculty of Pharmacy, Chemical Engineering, Chemistry etc)
• Have 3-4 years experience in regulatory field
• Have a good command of written and spoken English
• Strong command of communication and presentation skills
• Good knowledge of MS Office tools
• Strong planning, follow up, reporting and analytical skills to achieve accurate and timely results,
• Work precisely according to procedures, rules and regulations

*LI-GSK

Preferred qualifications:
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