Ra Associate

6 months ago

Dubai, United Arab Emirates Galderma Full time

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

RA Associate

UAE, Dubai

**Job Description**:
RA associate is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals.

The RA associate also needs to manage all the quality activities for the region as a back-up to the Quality Head.

In addition to regulatory affairs responsibilities the incumbent is responsible for supporting marketing promotional activities by reviewing and approving the promotional and non-promotional materials. In this role the individual will evaluate and assess the materials of our products for the Middle East markets.

Job Responsibilities- Reviewing & compiling dossiers for registration/ re-registration/ variation for sites and products across Middle East region.- Following up actively on all dossier submissions- Endeavoring constantly to anticipate and respond to regulatory/ technical queries- Achieving timely market-driven product submissions and registration approvals- Meeting product re-registration deadlines for marketing authorization renewals- Maintaining an informed awareness of regulatory guidelines- Coordination and communication between the corporate RA team and the distributors.-
- Archiving and maintenance of registration related documents & certificates- Preparation, follow up and revision of new or modified artworks text and ensure that Artwork changes are approved & implemented on time to meet MOH commitments and local / corporate compliance guidelines- Assist with quality processes, supporting preparation of SOPs- Review and approve the promotional materials for the marketing department and ensure that the approved materials are in line with the local laws and regulations for promotional practices.

Minimum Requirements- Pharmacist (preferred) or degree holder in Chemistry or Life Sciences- English Fluency- Minimum 3-5 years’ experience in pharmaceutical regulatory affairs in the Middle East- Computer literate, familiar with computer-based information systems, and new electronic documentation systems- Fluency in written and verbal English and Arabic is an add- Prior experience with Cosmetics registration and promotion in Middle East will be an advantage

Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website:
- Knowledge of Pharmacovigilance procedure will be an advantage.

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