JOB PURPOSE

Responsible for the regulatory affairs procedures for the assigned territory in Saudi Arabia

PRIMARY DUTIES

Responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.Develop effective relationships with local commercial organization, distributors and service providers if neededEnsure compliance with SFDA regulation as part of Responsible pharmacist duties in front of Saudi authorities;Provide regulatory guidance and advice on local country regulatory environments;Provide an assessment of the impact of new and changing regulations/requirements in Saudi ArabiaUse external resources to assist with the above tasks to not only meet timelines but expediting the time to market.

DUTIES & RESPONSIBILITIES

60% of the time;

In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management.Prepare and submit Takeda’s  market applications, variations, post-approval reporting obligations and general product life cycle management support for the applicable countries in Saudi Arabia;Prepare and maintain project plans and timelines of approvals and planned submissions.Ensure that Takeda’s products comply with the registration of health authorities in KSAPrepare (as needed) and review key application components and meeting materials and chair/attend meetings with regulatory agencies and participate in agency inspections as required.Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.Interact with distributors; service providers and regulatory agencies to resolve related review questionsAct as a point of contact for the assigned projects and as an interface with key corporate functional areas

20% of the time;

Ensure compliance of regulatory activities in Saudi Arabia consistent with Country laws and  Takeda’s  internal protocols and procedures (CMLR, Labelling compliance, etc) in coordination and liaison with GRA labeling and Ad/Prom GroupsReview and approve all promotional material in Saudi Arabia  and ensure MOH approval (Algeria)Ensure compliance with Saudi Arabia local regulation as part of Responsible pharmacist duties in front of MOHDevelop relevant regulatory department local operating procedures (CMLR, etc)Ensure regional regulatory documents, record-keeping in a secure, comprehensive mannerEnsure that all local product information used locally are up to date

10% of the time;

Provide guidance/advice on international regulatory environments, provide an assessment of the impact of new and changing regulations/requirementsDevelop effective working relationships with business partners and service providers in Saudi Arabia, including local visits as needed.

10% of the time;

Support the RA Head the ME & RA Head ICMEA and International RA team on specific projects as requested.

PRINCIPAL ACCOUNTABILITIES

Major Activities

Responsible for the regulatory affairs procedures for assigned territory.Liaises with the local health authorities and local distributors in regards to all regulatory affairs related issuesLiaises with the local distributors for submitting import permits for  pre-licensed productsUpdates Takeda with the most recent registration requirements and procedures for manufacturer’s and productsRequests registration files from DRA according to the latest registration requirementsReceives the registration files and makes the final check before forwarding to the local distributor for submission to the authoritiesLiaises with the distributor and health authorities for further documents and registration materials required by the MOH in its Post Meeting Follow UP Sheet (PMFS)Places the orders for buying chemicals and/or HPLC columns requested by the MOH DCLFollow up the last approval before pricingNegotiate with the MOH for product pricing on behalf of TakedaReceives the final registration certificate of the product and/or manufacturing siteSends a copy of the registration certificate and archives the original in the LOCKeeps records of all registration certificates and notifies IRA and local distributor six months before expiry so as to initiate the renewal process.Updates the IRA with the requirements for the renewal processReceives documents and registration material for renewal of registration 

Major Challenges

To comply with different requirements of products registration in KSA.Understanding the local market health authorities needs to develop proper registration strategies.Ensure uniformity and alignment of cluster/regional strategies, processes and policies.Proper utilization of resources to effectively implement the registration strategies.

Key Decisions Expected

Finalization of new products registration as per MRP.Execution of KSA Regulatory affairs strategies to achieve business objectivesExternal interface with health authorities and Takeda distributorsDay to day operational decisions

Dimensions

Geographical span: Saudi Arabia

SKILLS & KNOWLEDGE

Educational Qualifications

BA in a related field from a renowned institution/university

Relevant Experience & Knowledge

6 - 8 years of total experience5+ years of solid Regulatory Affairs experience in a medium to large size reputable organization/sExcellent in-depth knowledge of key business functions such as Sales, business development, marketing, Medical, etc.In-depth understanding of the pharmaceutical industry within the country

Personal Characteristics & Behaviors

Strategic thinker, innovative, able to drive multiple simultaneous initiatives, able to work under pressureMust be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.Excellent leadership, managerial, interpersonal and relationship building skillsExcellent verbal and written communication skillsGoal-oriented, focused, energetic, and enthusiasticIT savvy and process orientation