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Regulatory Affairs Manager

4 months ago

East Kilbride, United Kingdom Real Full time

Our client 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 and Export 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 reports

Deliverables:

  • Clear and consistent regulatory strategies, plans and communications, both internally and externally
  • Provision of RA support for all regulatory activities in the designated region, alongside direct reports
  • Provision of support to the RA compliance colleagues to support the development of core regulatory documentation systems
  • Establishment and maintenance an electronic RA audit trail for all activities in the 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 absent

Skills:

  • Written and oral communications skills including Arabic
  • IT skills (MS packages)
  • Formulate and enact regulatory strategy
  • Assimilate and evaluate scientific data
  • Knowledge of the regulatory framework and processes for different classes of consumer products
  • Knowledge of the regulatory framework in the EEA and UK
  • Understanding of the key functions that interact with RA within a "consumer" products company
  • Practical knowledge of regulatory compliance, publishing and document management systems
  • Regulatory Affairs and associated commitments

Qualifications:

  • Either degree in a relevant discipline or track record in a similar position
  • Fluency in Arabic

To find out more about Real please visit (url removed)

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy Registered office 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom Partnership Number OC(phone number removed) England and Wales