Regulatory Affairs Manager

3 weeks ago

East Kilbride South Lanarkshire, United Kingdom Real Full time

Our client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than 130 countries globally.

Driven by scientific research, technology, and keeping a pulse on consumers' aspirations, the global teams are dedicated to providing effective solutions for customer needs through developing high quality, innovative new products. To ensure continuity they are looking to add a Regulatory Affairs Manager to the team focused on Middle East operations. The position will report to the Head of Regulatory Affairs.

Position:

The Regulatory Affairs Manager will provide broad regulatory strategy, management and support for registrations and notifications in the Middle East / Export1 markets. Including working with direct reports to assure appropriate registrations and certifications for medicines, medical devices, cosmetics, and consumer (general) products, are in place to support the company with planning, establishing, monitoring, maintaining and growing its presence in these regions.

Duties:

Provision of advice and regulatory strategy for activities in support of new products in the region - in all categories (medicines, devices, cosmetics, general consumer products)
Communication with internal and international colleagues, and local distributor supporting RA functions, to ensure a clear understanding of the RA activities for the region
Management, mentoring, training and development of direct reportsDeliverables:

Clear and consistent regulatory strategies, plans and communications, both internally and externally, for the ME / Export region
Provision of RA support for all regulatory activities in the ME / Export region, alongside direct reports
Provision of support to the RA compliance colleagues to support the development of core regulatory documentation systems and assure visibility of regulatory commitments and compliance for the ME / Export region
Establishment and maintenance an electronic RA audit trail for all activities in the ME / Export region.
Routinely provide monthly and other progress reports to line management to record achievements, challenges and plans
Assure regulatory compliance is maintained
Ensure monthly report is delivered by the last working day of the month or earlier if absentSkills:

IT skills, MS Office (Word, Excel, PowerPoint. etc.)
(Once trained) Ability to work with Company software systems and resources.
Written and oral communications skills in both English and Arabic.
Formulate and enact regulatory strategy, and to assimilate and evaluate scientific data
Knowledge of the regulatory framework and processes for different classes of consumer products (medicines, devices, cosmetics, general products) in the Middle East and other "export" markets
Knowledge of the regulatory framework in the EEA and UK
Understanding of the key functions that interact with RA within a "consumer" products company
Experience
Responsibilities in RA for Middle East / Export markets.
Practical knowledge of regulatory compliance, publishing and document management systemsQualifications:

Either degree in a relevant discipline, preferably life sciences or track record in a similar position
Fluency in Arabic
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