Life Cycle Management and Compliance Manager

Julphar

UAE

Ref: OP009-14

Job description / Role

Employment: Full Time

The Life Cycle Management and Compliance Manager is responsible for life cycle of products; change controls, variations, re-registration/annual reports, deficiencies on variations/ re-registrations).

The position requires the preparation and inspection of high quality documentation to support for all regulatory submissions, primarily medicinal products, with minimum supervision; accountable in coordinating with related departments to guarantee that the submitted requirements are met. Proactively communicates with the regulatory authorities in order to accelerate the approval of submitted applications.

Main Responsibilities:
- Responsible for the assessment of applicability and impact of change controls; compilation of variation packages, re-registration of dossiers and annual reports.
- Coordinates with other departments (e.g., QA, IPD, Manufacturing) to get the relevant documents for all types of life cycle management.
- Organizes and coordinates effectively the life cycle management activities to subordinates and higher management.
- Provides forecast to possible challenges that might affect the life cycle programs and the amicable solutions as needed.
- Prepares the annual yearly life cycle management plan, and leads the execution on a timely basis.
- Resolves complex regulator issues, and provide input into the development of regulatory strategy.
- In charge to the preparation of component Modules of dossiers from clients data.
- Accountable for the preparation and management of post approval submissions.
- Provides developmental and strategic input into Companys processes and procedures.
- Represents the Company in a professional and positive manner to any opportunities for acquiring new approaches in cooperation with Company Directors.
- Reviews marketing activities and participates proactively in projects with either internal or external customers independently and communicates confidently.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior managers and directors as appropriate.
- Liable for the security and maintenance of regulatory documentation.

Requirements

- Has a degree in life science-related discipline. Masters degree is an advantage.
- At least 5 years Regulatory Affairs experience within the healthcare industry.
- Has an extensive Life cycle maintenance (post-approval) experience.
- Broad knowledge of GMP, GLP, and GCP regulatory requirements.
- Ability to work effectively without direct supervision.
- Has technical understanding of the CMC documents.
- Excellent knowledge of Regulatory guidelines across countries.
- Excellent communication skills, both oral and written.
- Strong understanding of the contents of regulatory life cycle management activities.
- Understands the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines.
- Proficient with MS office applications (word, power point, & excel). Knowledge of other software is an advantage.

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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