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Job description / Role
The Regulatory Affairs Coordinator of Biosimilar is responsible in assisting the assurance that the new products are well developed in line with the global registration requirements of target countries, and make sure to obtain practical registration of these products in a cost effective manner. Also, the position is accountable for the maintenance of registrations of existing products in compliance with applicable regulations. This position requires coordination, assistance, and supports the _____ (reporting to) as per the requirements of the development and execution of regulatory strategies, plans, and marketing applications for biosimilar products.
Main Responsibilities:
- Provides assistance in the development of regulatory strategies for projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.
- Supports the preparation of registration packages and responses to deficiency letters.
- Coordinates the submission data requirements and deliverable dates with regulatory authorities and technical teams.
- Prepares the agency letters pertaining to the assigned products/teams.
- Communicates the manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
- Supports the development, communication and implementation of global regulatory strategies of biosimalar goals and product portfolio execution.
- Collaborates with the development and execution of global clinical/non-clinical development strategies, including regulatory review of investigators brochures, clinical study reports, and related regulatory documents required to support product development and registration.
- Responsible for effectively communicate with partners and affiliates as required to ensure implementation of global regulatory strategies.
Requirements
- Bachelor's degree in pharmacy or related science.
- Excellent oral and written communication skills.
- Has good understanding of different agencies guidelines for biosimilar.
- Ability to compile a biosimilar dossiers for different agencies.
- Good time management and priority setting.
- Excellent interpersonal skills at all levels, including people-management, leadership and both written and verbal communication skills.
- Able to motivate, influence and encourage team members.
About the Company
Julphar is a true reflection of Ras Al Khaimah’s significant development. Established in 1980 under the guidance of H.H Sheikh Saqr Bin Mohammed Al Qasimi, we have established ourselves as a leader in production and distribution of pharmaceutical products.
Our goal is to create high-quality medicines whilst maintaining a competitive cost. We achieve this through a network of twelve world-class manufacturing plants (with further expansion planned) and a reliable logistics network which covers five continents.
We maintain a diverse product portfolio which target major therapeutic segments including endocrinology, anti-infective, cardiovascular and gastroenterology, over-the-counter, nephrology, dermatology, respiratory, metabolic and burn and wound management.