Dossier (Document) & Compilation Manager

Julphar

UAE

Ref: OP009-12

Job description / Role

Employment: Full Time

The Dossier (Document) Compliance Manager gives direction in everyday business operations by making sure that the Company is in accordance with the regulations established for the organizations industry.

The position is also responsible for all dossiers compilation documents; manage all company policies, procedures, work instructions, job aids, and compliance records to assure that the company dossiers meets the relevant health authorities requirement conformance with the appropriate standards and regulations.

Main Responsibilities:
- Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
- Responsible for the preparation of documents as per the compliance standard, and submission of regulatory agency applications, reports, or correspondence.
- Develops and implements strategic business and operating plans, organizations policies and procedures to ensure that regulatory dossiers compliance is achieved, well documented, or enhanced.
- Responsible in the assessment of regulatory agency submission materials to guarantee timeliness, accuracy, and comprehensiveness.
- Communicates with regulatory agencies regarding pre-submission strategies, compliance requirements, or justification and/or follow-up of proposal under review.
- Responsible for monitoring the emerging new trends of industry regulations to identify potential impacts on the processes of the organization.
- Accountable in maintaining and compiling the regulatory documentation dossiers, databases or systems.
- Liable for the development of risk management strategies to prevent non-compliance.
- Monitors the regulatory priorities or budgets and allocate resources and workloads.
- In charge for records control in which business processes data that needs to be recorded, and all forms that use to record data, and the storage and preservation of information as well.

Requirements

- Must be a degree holder of Bachelor of Science in Pharmacy or related field. Masters degree is an advantage.
- Experience in Compliance Documentation Management
- Has strong knowledge in identifying quality documents, documentation process, forms, and records.
- Must be good in communication skills, both oral and written; as the position requires a technical writer with familiarity in process mapping, process design, and policy and procedure writing.
- Proficient with Microsoft office such as word, excel, PowerPoint and visio. Knowledge with other software is an advantage.
- Excellent experience in Pharmaceutical is an advantage but not necessary.
- Dynamic, Team Leader, Enthusiastic and Service Oriented.
- Ability to work with different cultures and backgrounds

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.

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