Team Leader - RA | Julphar Jobs in Ras Al Khaimah
Team Leader – RA
Job: Full Time
Ras Al Khaimah, UAE
Julphar is a pharmaceutical manufacturer in the Middle East. Headquartered in Ras Al Khaimah, United Arab Emirates, the company employs more than 5,000 people and distributes its pharmaceutical products internationally
As a Team Leader RA will act as subject matter expert for all the regulatory compliance requirements and submissions. The role holder is expected to adhere with cGMP principles and to maintain them in an effective manner, develop monthly & annual plan to ensure regulatory compliance for products licenses renewals and other related activities in the functional areas of responsibility. Responsible to maintain and safeguard advanced corporate data bases of all dossiers submitted & approved for future reference. Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by Health Ministries. Organize task forces to address special department needs, provide input to strategies decisions that affect the functional areas of responsibility and develop reports for managements detailing the regulatory affairs
- Lead and support Regulatory Staff to ensure compliance with submission/approval annual plans for renewal and post approval changes and ensuring submission and approvals in Ministry of health on timely basis
- Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities
- Develop strong partnership with stake holder department and commercial teams to facilitate the development and implementation of registration strategies to enhance the portfolio
- Understand country needs and works to improve the quality of the database holding change requirement
- Coordinate with the Regulatory affiliates in countries, distributor and other concerned departments in order to fulfil the registration requirements
- 4 years Bachelor’s degree in Pharmacy or any related field
- Master degree in Pharmacy is recommended
- At least 6 -8 years’ experience in Regulatory Affairs in pharmaceutical industry
- Should have handled similar role for a better fitment of this role
For more details, please scroll down & see the details.
UAE – Julphar
|Title||Team Leader – RA | Julphar Jobs in Ras Al Khaimah|
|Job Location||Ras Al Khaimah, UAE|
|Employment Type||Full Time|
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*This Jobs was Originally Posted on Julphar Jobs Site..