Region: Gulf Countries
- 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.
- 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