Regulatory Affairs Manager

Description:

The incumbent 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.

This role reports directly into the Head of Regulatory Affairs – GCC Cluster.

Registration Planning

 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.

Dossier preparation, submission and product Approval

 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.
 Support achieving product pricing for new products as per agreed plan.
 Ensure proper communication/archiving of all documents submitted to the local Health Authorities as required.
 Ensure consistent and transparent communication of regulatory timelines, changes to timelines to Head of regulatory GCC and business partners.

Regulatory Compliance

 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.
 Tracking of regulatory commitments
 Manages local regulatory interactions with Health authorities to support product recall when necessary.
 Ensures all regulatory activities are performed in line with local regulations.
 Review promotional materials and ensure content is in line with local regulations, corporates SoPs and regional code of practice.

Regulatory intelligence

 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.
 Provides Competition intelligence and/or interpretation of business impact to local stakeholders as required.
 Liaison and relationship building and information sharing with GCC Regulatory team.

Regulatory Influence 

 Establishes and maintains regular, strong and trustworthy relationship with regulatory officials.
 Communicates with the local distributor to ensure optimized and compliant regulatory procedures.
 Maintains contact and liaises when needed with key business partners, internally and externally.

Qualifications

 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