Head of Regulatory Affairs

ROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Turkey, Southern Africa (South Africa & Sub Sahara Africa) Northeast & West Africa, Near East & UAE, Saudi Arabia, Gulf & East Africa (SAGEA).

IMETA is home to more than 47 nationalities. We are a powerhouse of talent, and we work together to ensure that we grow, nurture, and retain our talent. Uniting and working together is the key to our success.

The Position

We are hiring a Head of Regulatory Affairs (RA), responsible for SAGEA based at Riyadh, reporting to the Medical Director SAGEA. The Head of RA collaborates with regional Regulatory Affairs to optimize and implement regional regulatory strategies for local markets. Maintains product registrations, ensures business continuity, while complying with internal and external regulations. The Head of RA partners with local management to set business strategies. Fosters strong interactions with authorities across the region and plays a leadership role within the local pharma association. Contributes to the setup of localization and local production.

Tasks & responsibilities

• Advice business on any new regulatory opportunities or risks arising in the RA environment to allow business to realize growth opportunities or avoid losses.
• Ensure proper budget allocation, resource planning and the right strategic prioritization.
• Maintaining product license to ensuring business continuity and monitor RA compliance against internal and external regulations and requirements.
• Advice local business on evolving RA risk and opportunity to ensure business realization of growth opportunities or avoid losses.
• Partner with local management team to set the local business strategies and develop local RA talents to accommodate business need.
• Supports on topics for regional and global projects.
• Interact and partner with Health Authorities playing a leadership role within the local pharma association.
• Play an important role in the setup of any localization and local production.
• Lead and manage development of the RA team.

Requirements

• Bachelor's degree in Pharmaceuticals is required
• 5+ years of extensive pharma experience with 4+years of experience into regulatory affairs in a multinational company
• 2-3+ years of leadership experience with a proven track record of building high-performance teams.
• Previous experience and efficient interaction with local Regulatory Authorities
• Knowledge of local and awareness of international regulatory affairs regulation
• Business fluent in English in its oral and written form
• Previous experience within French speaking African countries will be an asset
• Strong organizational and communication skills
• Proactive and assertive attitude
• Must be a Saudi National