Regulatory Affairs Specialist
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Key skills for this role
About the Role
Bausch + Lomb is seeking a Regulatory Affairs Specialist to ensure compliance with regulatory requirements for pharmaceutical products, food supplements, and medical devices in the Middle East region.
Key Skills for This Role
Responsibilities
- Prepare and support preparations of new registration files according to country regulatory guidelines for pharmaceutical products, Food supplements and medical devices
- Maintain and manage registrations for existing products with local and regional health authorities
- Prepare and submit variations, renewals, updates and amendments for existing products
- Ensure timely submissions of all activities to relevant health authorities
- Monitor and ensure compliance with local regulations, guidelines, and industry standards
- Liaise with regulatory authorities to resolve compliance issues and ensure timely approvals
- Create, develop and maintain labelling and artworks files according to country labelling guidelines
- Review promotional and advertisement materials according to local legislations
- Strong collaboration with global/EMEA/MEA/local Regulatory affairs teams for assigned projects
- Regular reporting of Regulatory submissions, approvals, updates, challenges and new guidelines to MEA Head of department
- Support cross functional teams (quality, commercial, supply chain) on regulatory requirements
- Manage and collaborate with distributors, service providers and authorized representatives in the region
Requirements
- Bachelor’s degree in pharmacy, Life Sciences, or related field
- 2–4 years of experience in regulatory affairs for Pharmaceuticals and Medical devices as a must
- Strong knowledge of regulatory requirements for product registration and life cycle management
- Fluency in English and Arabic, both spoken and written communications
- Significant attention to detail and excellent organizational skills
- Effective communication and interpersonal skills
- Ability to work independently and manage multiple tasks in cross functional environment
- French will be a plus
Full Job Posting
Role Objectives
- The Regulatory Affairs Specialist ensures that all new and existing products and operations comply with applicable regulatory requirements.
- The role focuses on sustaining market authorization, managing regulatory obligations, and supporting business continuity through proactive regulatory management.
- Ensure compliance with the company policies and procedures and with external regulations.
- Support all regulatory activities in Middle East region.
- Coordinate regulatory activities between the local authorities, EMEA/ Global Regulatory Affairs, distributors and business.
Key responsibilities
- Prepare and support preparations of new registration files according to country regulatory guidelines for pharmaceutical products, Food supplements and medical devices.
- Maintain and manage registrations for existing products with local and regional health authorities.
- Prepare and submit variations, renewals, updates and amendments for existing products.
- Ensure timely submissions of all activities to relevant health authorities.
- Monitor and ensure compliance with local regulations, guidelines, and industry standards.
- Liaise with regulatory authorities to resolve compliance issues and ensure timely approvals.
- Create, develop and maintain labelling and artworks files according to country labelling guidelines.
- Review promotional and advertisement materials according to local legislations and support on obtaining health authorities’ approvals.
- Liaise with regulatory authorities for follow up to resolve regulatory challenges and ensure timely approval.
- Strong collaboration with global/EMEA/MEA/local Regulatory affairs teams for assigned projects and tasks.
- Regular reporting of Regulatory submissions, approvals, updates, challenges and new guidelines to MEA Head of department.
- Support cross functional teams (quality, commercial, supply chain) on regulatory requirements impacting business continuity.
Qualifications & Skills
- Bachelor’s degree in pharmacy, Life Sciences, or related field.
- 2–4 years of experience in regulatory affairs for Pharmaceuticals and Medical devices as a must.
- Strong knowledge of regulatory requirements for product registration and life cycle management.
- Fluency in English and Arabic, both spoken and written communications, French will be a plus.
- Significant attention to detail and excellent organizational skills.
- Effective communication and interpersonal skills.
- Ability to work independently and manage multiple tasks in cross functional environment.
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