Senior Regulatory Affairs Manager - Saudi Arabia

Job DescriptionPurpose: The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, International Growth markets (IGM), Development, Chemistry, Manufacturing and Control (CMC) Regional contacts as well as relevant global, regional and local stakeholders.He/she will lead local regulatory activities in KSA to ensure strategic contribution to early-stage pipeline development and submissions and registered product lifecycle management strategies (clinical, labelling & CMC), as appropriate.This role reports directly into the Head of Regulatory Affairs – GCC Cluster.Registration PlanningWork according to the strategic directions defined by the Head of Regulatory Affairs – GCC and GCC commercial organization,Responsible for development and execution of registration strategy and plans for products under his/her responsibility in line with the regional regulatory strategy, business plans and objectives (including expected submission & approval timelines)Responsible for developing and growing relationships and working processes with global, regional and local stakeholders, to ensure optimal support and communication.Responsible for providing inputs of anticipated market specific regulatory issues for planned submissions, local strategic guidance, insights, interpretation, advice and updates related to KSA market based on the local laws, requirements and market practice.Dossier Preparation, Submission And Product ApprovalWorks closely with the local and regional Regulatory Teams, International Growth Markets (IGM) team representatives, in-country Business units teams and other internal and external stakeholders, as necessarySupport Market-specific file compilation, support preparation of market-specific documents e.g. application forms, clarification letters, in collaboration with the IGM regulatory team.Accountable for leading country regulatory submission activities for new product & life-cycle management activities for registered products.Executes the agreed plans by coordinating dossier submission within agreed timelines and obtains Drug Regulatory Agencies approvals for new chemical entities (NCEs), line extensions, new indications and site registration to meet the affiliate launch plans.Ensure submitted product documents fully meet the local regulatory requirements for KSA market.Follow-up with the local distributor (when applicable) and regulatory authorities during submission, file review and ensure all questions /requests are provided/clarified within due time to ensure timely approval of the product.Support achieving products registration and 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, business partners and IGM colleagues.Regulatory ComplianceRaises 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 SFDA/GHC.Initiates, manages and oversees the labelling and artworks development process (review, approval, implementation) within agreed timelines, in line with internal SoPs), corporate guidance 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 commitmentsManages local regulatory interactions with Health authorities to support product recall when necessary.Ensuress regulatory activities are performed in line with the internal SoPs, WI and local regulations.Review promotional materials and ensure content is in line with local regulations, corporates SoPs and regional code of practice.Regulatory intelligenceEnsures contemporary contribution to Central Regulatory Intelligence/Interpretation and ExperienceUnderstand the local regulatory guidelines and requirements for the country 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 Biogen products and/or operations.Provides Competition intelligence and/or interpretation of business impact to global and local stakeholders as required.Liaison and relationship building and information sharing with regional regulatory and IGM Teams.Regulatory Influence Establishes and maintains regular, strong and trustworthy relationship with regulatory officials.Accountable and responsible as main Biogen contact for interactions with external regulatory authorities, expert panels, advisory committees, cooperative groups. Leads local Agency engagement strategy in collaboration with local and regional stakeholders as required.Represents Biogen in regulatory forums and working groups of local industry associations.Communicates with the local distributor to ensure optimized and compliant regulatory procedures.Maintains contact and liaises with key business partners, internally and externally.Collaborates internally with all corporate functions when needed to pro-actively provide regulatory input and guidance.CapabilitiesAutonomous, Proven leadership and interpersonal skills,Cultural awareness, High emotional intelligence and collaborative decision-making approach,Must build relationships throughout and across the organization whilst operating remotely,Exceptional organizational and project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities,Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities,Ability to impact and influence the decisions of a team, external parties, and higher-level groups,Effective presentation skills. Confident and proficient at communication with relevant external bodies and internally at all levelsQualificationsA minimum 5 years’ experience in Regulatory Affairs in KSA; Regulatory experience in other GCC markets would be a plus.Demonstrated strategic regional regulatory thinking and risk assessment capability.Broad knowledge of KSA and other 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 KSA. Good experience in interfacing with relevant regulatory authorities (Saudi FDA, Gulf Health Council); Effective and positive interactions with regulatory agencies, and corporate 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 assessmentAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts