Regulatory Affairs Manager/Head GCC (Saudi National)

The Company

Multinational Organization

Region: Gulf Countries

Key objectives

  • Contribution to the development and implementation of commercial objectives and strategies in the markets under the scope.
  • Management of new registrations and products licenses maintenance activities.
  • Supervising the regulatory team in GCC region.
  • Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.  Leverage regulatory intelligence/landscape knowledge to support the development and implementation of regulatory and business strategies.

Key Responsibilities:

New registrations

  • Responsible for Marketing authorization Application Submission at health authorities in GCC countries, communication with local distributors (regulatory department) and Authorities for final approval of license.
  • Active role in interpretation of queries raised by authorities.

Product maintenance – Variations & Renewal

  • Requesting registration documents required to approve variations and license renewal at MOHs, compiling, submission and follow up for final approval.
  • Active role in interpretation of queries and letters of deficiency raised by authorities
  • Tender Support:
  • Request, compile and submit the registration documentation required for tenders and customs clearance on time.
  • Coordinate with business leads, Marketing, Franchise RA and Supply chain to define strategy, approach and provide technical expertise that support Company products over competition. 

Cooperation with Supply chain:

  • Collaboration and update SC on product changes (e.g. shelf life, specifications, source country and packaging materials), update on approval status to ensure only compliant products supplied to markets.
  • Updating the logistic department with the regulatory issues that may affect on the product dispatch and clearance in countries.

Interaction with Authorities

  • Managing good working relationship with authorities, involved in regulatory review and decision, in GCC countries.
  • To ensure that the company’s regulatory and statutory requirements are met.
  • Ensure timely notification of complaint, vigilance, field safety corrective action and recall activities to relevant authorities.

Regulatory intelligence – Legislation,

  • Scan the external environment and do lobbying activities e.g. liaising with other local market-based colleagues (e.g Industry group) to facilitate the review and approval of regulatory submissions. 
  • Providing regulatory and legislation insights and better interpretation about MDs regulations change and potential impact on business to local business leads and CEO lead.
  • To work with Regulatory Regional, thus ensuring local needs are considered in Global / Regional regulatory strategies which support the strategic planning process, local inputs to dossier development

Profile and Qualification:

  • Confident and clear in communicating.
  • Strong organizational and time management skills with an ability to work under pressure.
  • Capable to persuade and influence at the highest level.
  • Possesses a Global mindset with an ability to make decisions based on broad standards; follows global trends and assesses local impact; develops global networks and demonstrates horizontal leadership.
  • Finds innovative solutions to business problems, and right from the concept stage provides the regulatory route(s) to a solution.
  • Able to build effective working relationships and deliver results in wide range of environments and cultures.
  • Language: English & Arabic is a must
  • Education: BA Life-science/Pharmacy or related
  • Has a good tracking record in Regulatory (min. 8-10 years), at least 3 years Managerial level
Job Category: Executive
Job Type: Full Time
Job Location: Jeddah Kingdom of Saudi Arabia

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