Regulatory Affairs Specialist

Contract: 1 year (renewable)

Employment: Outsource through ManpowerGroup Middle East

Role Summary:

The Regulatory Affairs Specialist will be working with local health authorities, local distributors (or company partners) and different departments within global and local company. This person will help cover regions such as Bahrain, Kuwait, Qatar, Oman, the UAE, Lebanon, Jordan, Egypt and other local representative markets.

Key Accountabilities:

• Prepare and manage new product submissions for regulatory approval to the local Health Authority (HA), both eCTD and paper submissions.
• Liaise with global regulatory colleagues to execute the approved regulatory filing strategies for the region.
• Labelling:Prepare files, liaise with partners, submit to HA, track, archive and manage label update submissions across Middle East.
• Prepare and submit for HA review - CMC amendments to product dossiers.
• Respond to HA queries on both new product and amendment submissions.
• Life cycle management of registered drug products.
• Keep track of periodic license renewals and submit to HA so as to maintain uninterrupted supply of drugs to patients.
• Liaise with local marketing and market access divisions to provide regulatory support. This includes formal quarterly regulatory feedback sessions.
• Review and approve all local artwork.
• Participate in site to market meeting with the cross functional teams to plan new product launch.
• Attend quarterly Gulf compliance committee meetings and keep track of compliance topics.
• Regulatory review of promotional material and clinical trial study medication labelling.
• Communicate with HA regarding initiated product license withdrawals and recalls, as per the directions from Global/SOP.
• Liaise with local partners to manage day to day regulatory activities in the region.
• Update VERITY (Regulatory information repository), local archives and local labelling SharePoint

Qualifications and Requirements:

• Bachelors Degree in Science and/or Pharmacy
• Professional experience with 3-4 years of relevant regulatory affairs experience in the region (any of the countries mentioned above), preferably in Pharma industry.
• Up-to-date regulatory affairs and industry knowledge.
• Ability to execute with accuracy, sense of urgency, good communication skills.
• Must be a team player, agile and willing to take up additional projects as per the company's requirement.