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Regulatory Affairs Officer

Ghobash Group

Dubai, UAE

Ref: GP773-226

Job description / Role

A subsidiary of Ghobash Trading & Investment Co. Ltd., a leading organization in the UAE with established business in the fields of Information Technology, Chemicals, Oil Fields Supplies, and Healthcare.

It is now looking to hire a Regulatory Affairs Officer.

Job Purpose

The job holder is responsible for management and facilitation of registration related to Pharmaceutical, Veterinary and Medical. She/he builds relationship with regulatory authorities; coordinates with Logistic teams to provide regulatory input in order to obtain timely regulatory approvals for the products; handles quality related queries / complaints; and stays updated on regulatory aspects pertinent to business development.

Key Responsibilities

- Complete registration formalities for Pharmaceutical, Veterinary and Medical
- Review regulatory documentation and technical product information
- Provide regulatory support for portfolio of products
- Establish and update registration database in the company
- Update licenses and collect information on registration instructions and regulations
- Provide and complete forms need in registration
- Complete forms and requests originating from government agencies (DM)
- Carry out all subsequent follow up and pricing negotiations necessary to obtain the approval
- Checking all import permits
- Maintain contact with regulatory authorities
- Communicate with regulatory bodies in DM & MOH to facilitate successful product launch.
- Establish healthy & effective relationship with all concerned personnel at DM.
- Provide the Logistic teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
- Update Logistic team on products for shipment.
- Ensure approval of import permits by DM.
- Deal with quality related questions and complaints
- Follow up and update all existing registration dossiers & handling minor change variations that crop up from time to time
- Ongoing visits and intensive call to all concern people
- Timely accurate solutions to all complaints

Perform Pharma co-vigilance activities

- Prepare pharma co-vigilance SOPs as required by our principals.
- Train the company staff as per the SOPs.
- Follow up for any reported safety case.
- Providing required documentation to principals during occasional PV audits.

Requirements

Job Requirements

Educational Qualification Requirements
- Bachelor’s Degree in Pharmacy

Skills & Professional Requirements
- Knowledge & experience of regulatory process
- Knowledge of DM, MOH and government regulations relevant to AEC products
- Fluent in English and Arabic languages

Experience Requirements
- 4-5 years of relevant work experience

About the Company

Incepted in the late 70's, Ghobash Group has become one of the resilient business conglomerates in UAE. The privately-owned group has expanded to geographies across the Middle East, Asia, Africa and Europe through its diversified business arms.

Focused on growth through value-creation, Ghobash Group has advanced with successful milestones over the years in its business industries: Technology, Chemicals, Engineering, Oil & Gas, Water, Energy, Pharmaceutical, Retail, Trading and Real Estate.

CNS, GCG Office Imaging, Tawazon Chemical, E&I Emirates, GCG Engineering Services, Arabian Ethicals, Ataya Fashion, Prime Hospitality, and Makeen Properties. The Group has also formed Joint Ventures over the years such as Sahara Center sustaining its momentum of successful milestones throughout the years.

Sustainability, innovation, diversification, and ownership are amongst the key values the Group has been practicing for decades. Working with partners, who share the same values, the Group has added value throughout the years through profitable investment opportunities in both the private and public sectors.

In depth experience, combined with a granular knowledge of the regional economy, enables Ghobash Group to identify, and provide access to the best business opportunities across the region.

Committed to diversified growth, Ghobash Group is headquartered in the United Arab Emirates and services through its offices and factories in Saudi Arabia, Oman, India, Iraq, and Africa.

The Group values its people as family and its customers as long term partners. Embracing excellence yet keeping it personal is a key strength of the Group which is a characteristic that has not faded since its inception.

Driving success through its people and partners, with its diverse business arm, Ghobash group aims to continue to grow adding value with every opportunity, every transaction, every employee life, every partner business, every community across varied geographies.

Together we make a difference.

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