Regulatory Affairs Manager

Manpower Middle East; Dubai; Sur place; AED 240 000 - 420 000; Plein temps

Résumé du poste

Manpower Middle East is seeking a Regulatory Affairs Manager for a leading biotechnology client in Dubai. The role leads regulatory activities to secure MAAs and post-registration variations within agreed timelines, working with GCC regulatory and commercial teams.

The ideal candidate has 8–10 years in Regulatory Affairs in the GCC, deep knowledge of local regulations, and proven ability to coordinate submissions and interact with health authorities and external partners.

Qualifications

• 8–10 years of Regulatory Affairs experience in GCC
• Strong knowledge of GCC pharmaceutical legislation
• Excellent communication with authorities and cross-functional teams
• Fluency in Arabic and English

Responsabilités

• Lead regulatory submissions for new products and life-cycle activities
• Develop and execute registration strategies per GCC requirements
• Coordinate with Health authorities and local distributor
• Collaborate with cross-functional teams and stakeholders

Connaissances

Regulatory strategy

GCC regulatory knowledge

Stakeholder management

Arabic & English fluency

Formation

Health-related sciences background (B.A. or B.S.)

Description du poste

Employment: Outsourced through Manpower Middle East

About the Role:

Our client, one of the leading companies in Biotechnology, is seeking a Regulatory Affairs Manager to join their team. As a Regulatory Affairs Manager, you will work in close collaboration with GCC Regulatory and commercial organizations, as well as relevant local stakeholders. He/she will lead regulatory activities for the assigned portfolio to ensure submissions and approval of new marketing authorization applications (MAAs) and post-registration variations within the agreed timelines.

About the Requirements:

• Work according to the strategic directions defined by the Head of Regulatory Affairs – GCC and in line with GCC commercial organization objectives,
• Responsible for development and execution of registration strategy and plans for product(s) under his/her responsibility in line with the regional regulatory strategy, business plans and objectives (including expected submission & approval timelines)
• Responsible for providing inputs of anticipated market specific regulatory issues for planned submissions, local strategic guidance, insights, interpretation, advice and updates related to GCC markets based on the local laws, requirements and market practice.
• Works closely with the Regulatory and cross functional teams and other internal and external stakeholders, as necessary
• Support Market-specific file compilation, support preparation of market-specific documents e.g. application forms, cover letters, clarification letters, in collaboration with the Head of regulatory GCC.
• Accountable for leading country regulatory submission activities for new products & life-cycle management activities for the registered products.
• Executes the agreed plans by coordinating dossier submission within agreed timelines and obtains Drug Regulatory Agencies approvals for new chemical entities (NCEs) as well as post-registration variations.
• Ensure submitted product documents fully meet the local regulatory requirements for GCC markets.
• Follow-up with the local distributor and regulatory authorities during submission, file review and ensure all questions /requests are provided/clarified/addressed within due time to ensure timely approval of the products.
• Ensure consistent and transparent communication of regulatory timelines, changes to timelines to Head of regulatory GCC and business partners.
• Raises awareness and advising impact of developing lifecycle asset activities to the Head of Regulatory GCC.
• Maintains products license and ensure all marketed products in the country are in compliance with local and corporate regulatory requirements, i.e. labeling (Product Information and packaging development); label change management; Chemistry, Manufacturing and Control commitments submitted to the local Health Authorities.
• Initiates, manages and oversees the labelling and artworks development process (review, approval, implementation) within agreed timelines and local Health Authorities regulations.
• Review English labels and its Arabic translation and follow up with external supplier on proposed changes implementation.
• Manages local regulatory interactions with Health authorities to support product recall when necessary.
• Ensures contemporary contribution to Regulatory Intelligence/Interpretation and Experience
• Understand the local regulatory guidelines and requirements for the countries under her/his responsibility and effectively communicate to the regulatory and business colleagues in a timely manner any change in the regulation that could have impact on the products portfolio and/or operations.
• Establishes and maintains regular, strong and trustworthy relationship with regulatory officials.
• Communicates with the local distributor to ensure optimized and compliant regulatory procedures.

Experience

• Health Related sciences background and education (B.A or B.S; advance degree such as Masters’ would be a plus).
• A minimum 8-10 years’ experience in Regulatory Affairs in GCC region.
• Demonstrated strategic regional regulatory thinking and risk assessment capability.
• Broad knowledge of GCC countries pharmaceutical legislation.
• Strong ability to understand, interpret and apply local regulations, guidelines, policy statements, and influencing/advising the operations accordingly.
• Proven track records of fast-track registration in GCC. Good experience in interfacing with relevant regulatory authorities.
• Effective and positive interactions with regulatory agencies, and external partners.
• Ability to assimilate new knowledge rapidly and deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound.
• Good Analytical skills, accuracy and reliability.
• Demonstrated capability of strategic regional regulatory thinking and risk assessment.
• Fluent in Arabic and English language.

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About ManpowerGroup, Parent Company of Manpower, Experis and Talent Solutions

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis and Talent Solutions – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are consistently recognized for our commitment to diversity, inclusion, equality, and ethical business practices, including being named one of the World’s Most Ethical Companies multiple times.