Regulatory Affairs

Job description / Role

Our Client is looking for a for a Regulatory Affairs Specialist (12 months renewable)

This is a Contract role under Manpower ME.

Job Description:
• Responsible for handling the regulatory procedures for the assigned territory including new drug applications and life cycle maintenance activities.
• Active involvement in the ensure timely submissions & approvals as per the planned strategy to meet the launch timelines.
• To Prepare & revise the responses to Deficiency letters by the authorities during the evaluation process within a specific time frame
• To establish and maintain professional relationships with business partners and Health Authorities
• Cross-functional support including Operations & Supply, Pricing & Market Access and Marketing departments based on the business need.
• PV responsibilities across the assigned territory including PSUR planning, timely PSUR submissions, Audit preparation & responding to questions and labeling updates.
• To ensure full understanding & compliance with the continuously changing regulatory environment.
• To maintain the Life cycle for the currently registered portfolio including Renewals & Post approval changes.
• Close follow up and monitoring of the regulatory activities with the local representatives in the assigned region by exchanging monthly reporting, TCs & face-to-face meetings
• To maintain a full up-to-date database for tracking the regulatory activities in the assigned region
• To support the global graphic design team in the preparation of mock-ups and artworks, and providing the needed approval on timely manner.
• To Handle ad-hoc requests and tasks efficiently
• Liaises with the local health authorities and local distributors in regards to all regulatory affairs related issues
• Liaises with the local distributors for submitting import permits for pre-licensed products
• Updates the Client with the most recent registration requirements and procedures for manufacturer’s and products
• Requests registration files from DRA according to the latest registration requirements
• Receives the registration files and makes the final check before forwarding to the local distributor for submission to the authorities
• Liaises with the distributor and health authorities for further documents and registration materials required by the MOH in its Post Meeting Follow UP Sheet (PMFS)
• Places the orders for buying chemicals and / or HPLC columns requested by the MOH DCL
• Follow up the last approval before pricing
• Negotiate with the MOH for product pricing on behalf of the Client
• Receives the final registration certificate of the product and / or manufacturing site
• Sends copy of the registration certificate and archives the original in the LOC
• Keeps records of all registration certificates and notifies Global RA nd local distributor six months before expiry so as to initiate the renewal process.
• Updates the Global RA with the requirements for renewal process
• Receives documents and registration material for renewal of registration

Requirements

• Candidate should have 2-3 yrs Regulatory Experience
• Arabic & English speaking
• Able to multi- task
• Flexibility
• Should be able to work in a diverse environment

About the Company

We lead in the creation and delivery of innovative workforce solutions and services that enable our clients to win in the changing world of work.

ManpowerGroup powers the success of many of the world's most dynamic organizations. We deliver innovative workforce solutions that enhance competitiveness, increase efficiency and spur productivity. Combining global reach with local expertise - 3600 offices in over 80 countries - we know the changing world of work and bring a deep understanding of the companies we work for and the industries we service.

ManpowerGroup entered the Middle East in December 2007 after acquiring local company Clarendon Parker, thus bringing 15 years in-depth local knowledge combined with a global footprint and industry shaping expertise and thought leadership. Manpower Middle East supports clients in the Middle East and North Africa regions. Our business is aligned to key skill specializations to ensure our clients requirements are met by expert and knowledgeable consultants that understand your industry and role requirement.

Our consultants are experts in finding the right talent across all industries in a broad-range of occupations including:

• IT & Telecommunications
• Engineering & Construction, Oil & Gas
• Banking, Finance & Legal
• Sales & Business Development
• Marketing, Public Relations & Communications
• Human Resources & Training
• Customer & Support Services (Secretarial and Administrative)
• Operational, Supply Chain & Logistics
• Executive Recruitment
• Emiratization Solutions
• Recruitment Program Outsourcing Solutions
• Managed Service Provider Solutions
• Talent Based Outsourcing Solutions
• Outsourced Staffing Solutions