Regulatory Affairs Officer - 12 Months Renewable Contract

Job description / Role

Position Purpose: Manage Clients product licenses/registrations in a country/or group of countries within MENA from initial submission/approval and throughout the product life cycle

The Regulatory Officer provides regulatory expertise for and executes the:
- Submission Planning and management of the new products (including product line extension and new indication registration)
- Regulatory maintenance of marketed products (including product maintenance as manufacturing or labelling variations, renewals, etc.)
- Collaborate and establish a network with business partners

Primary Responsibilities

Registration Planning:
- Development of registration plan for products/markets under his/her responsibility. Including local requirements and expected approval timelines
- Provides inputs of anticipated market specific regulatory issues for planned submission
- Inputs/feedback into MENA registration plan for new product

Dossier Submission and product Approval:
- Market-specific file compilation, preparation of market-specific documents e.g. application forms, summary sheets and clarification letters.
- Executes the agreed plans by coordinating dossier submission through distributors in each market within planned affiliate timelines and obtain Drug Regulatory Agencies approvals for new chemical entities (NCEs), line extensions , new indications and site registration to meet the affiliate launch plans
- Ensure submitted product documents will fully meet the local regulatory requirements for markets of responsibility
- Follow-up with the regulatory authority during submission review and ensure all questions /requests are provided/clarified within due time to ensure timely approval of product.
- Achieve products registration and pricing for new products as per agreed plan
- Act as first point of contact with regulatory personnel at distributors.

Regulatory Compliance:
- Ensure that all marketed products in the country are in compliance that meet local and corporate regulatory requirements, i.e. labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that were registered with the MOH.
- Ensure local label creation will meet local and corporate criteria by providing the necessary inputs
- Tracking of regulatory commitments
- Archive and maintain GMP related records according to local, global SOP’s
- Participate in local regulatory actions (contact with authorities) to support product recall

Regulatory Influence
- Maintain regular contact/relationship with key regulatory officials
- Maintain contact and liaise with key business partners, internally and externally.
- Understand the local regulatory guidelines and requirements for the country/countries under their responsibility.

Requirements

- Technical Skill Requirements
- Organization and Planning
- Analytical skills, accuracy and reliability
- Communication Skills
- Good oral and written communication skills
- Ability to handle multiple Projects and interact with a variety of business components
- Initiative, networking
- Teamwork/Collaboration
- Language Fluency: English, Arabic
- Min 1-2 Years’ Experience in Regulatory Affairs within the industry or an official environment/regulatory body

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