Head of Regulatory Affairs META

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Head of Regulatory Affairs META

UAE, Dubai

Job Description

Lead Regulatory Affairs strategy, its programs and polices and provide strategic direction to regulatory activities on both new and in-line products in accordance with health authorities to define registration strategy and planning.

Role in Middle East, Turkey, Russia and Africa (META) Leadership Team role, and first point of contact for Regulatory for the General Manager of META.

Lead a team of 8 direct reports across UAE, Saudi Arabia, Turkey, Russia, and South Africa.

Job Responsibilities

• META LT role and first point of contact for Regulatory for the GM of META.

  
  

• Lead, shape, drive and execute all Regulatory Affairs priorities for all product classes (medicinal products, medical devices, cosmetics) across META

  
  

• Lead and manage the entire registration process, ensuring approvals of new products, manufacturing permits, import permits, and amendments to products

  
  

• Lead regulatory strategy development to enhance speed to market for new product development, and lead execution. Ensure new license applications are submitted within agreed project timelines, and approvals are obtained as planned.

  
  

• Ensure compliance with, and maintenance of, existing licenses.

  
  

• Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.

  
  

• Team leadership. Build functional capabilities to enable growth. Manage resources capacity/allocation for required activities.

  
  

• Lead interactions and negotiations with Health Authorities UAE and drive and oversee those in other markets, in connection with Pharmacists in Charge / Scientific Office managers, where applicable.

  
  

• Shape the regulatory environment, driving an agenda to create an external environment in which our portfolio can thrive. Build a network with external experts.

  
  

• Partnership with distributors and agents, where applicable

  
  

• Ideally, has the credentials to take the role of Scientific Office Manager for Galderma Middle East (GME).

  
  

Minimum Requirements

• Pharmacist Degree (PharmD)/ Bachelor’s degree in pharmaceutical science.
• Preferred  UAE MOH licensed pharmacist (with active certificate)
• 12 years’ experience in Regulatory Affairs, with at least 5 years in a team-leading role across multiple territories.
• Hands-on technical experience in Middle East and(oversight) experience in one or more of the other territories (Russia, Southern Africa, Turkey)
• Experience in the field of medicinal products and with additional relevant experiences in medical devices and/or cosmetics.

Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website: https://www.galderma.com/careers