Regulatory Affairs Associate Director

Job Description

Basic Functions & Responsibility:

For assigned products ensures timely preparation submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and as applicable to the EMA.

Ensures maintenance of assigned authorized products through timely submission of variations renewal applications and supplemental marketing authorizations.

For assigned products ensures timely accurate and compliant labelling translations and artwork preparation.

Supports the agency interactions to ensure a seamless submission assessment and quick approval of the CTAs according to the new EU CT Regulation in cooperation with RAE Liaison and other internal stakeholders.

For assigned products and tasks stays updated on late our companys pipeline filings relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans as necessary.

Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.

For assigned products and tasks works alongside the BD locally regionally and globally to support business initiatives in sub region.

Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional regional and global level EUQPPV and GCS&PV are the main contact points within the company. External contacts are regulatory authorities as well as other key players in the regulatory environment.

By discretion of Regulatory Affairs Management and due to organization and workload all listed activities need not to be performed.

Applicable to incumbent with direct reports only: Responsible for people management of applicable Regulatory personnel in Saudi Arabia and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.

Acts as substitute for Country Lead Regulatory Affairs as appropriate.

Major Activities

Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing medical finance customer service marketing and external affairs departments GRACS on sub-regional regional and global level as well as with local regulatory authorities as appropriate depending on procedure type. Coordinates and implements early access programs with the Agency. Tracks process and manages answers to objections from the Agency on products registration and major new indications involving negotiations to achieve best conditions.

Designs and implements local action plans for new products involving selection and regulatory training of external experts and closely interacting with the Agency and Advisory Committee members with continuous interface with RAE.

Maintenance of licenses for assigned products

Ensures that marketing authorizations are maintained in compliance with related regulatory areas through performing the necessary activities including variations and renewals with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.

For major indications designs and implements local action plans as above mentioned for new MA applications.

Compliance

For assigned products ensures timely preparation and maintenance of local Summary of Product Characteristics Patient Package Inserts local physicians circulars packaging material and other applicable regulatory documents according to our companys and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.

Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.

Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.

Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.

Ensures that files and archives related to Regulatory are kept updated and complete.

Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.

Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labelling and artwork

Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.

Ensures availability of packaging material including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Cross-functional activities

Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials.

Ensures adequate support to other functions to enable compliance in areas related to regulatory such as PSUR submissions and review of promotional material.

Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.

Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team such as deletions divestitures and acquisitions.

Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.

Participates provides active input and lead if the case the local Medical Governance.

Regulatory policy & environment

Keeps abreast of local and international laws collects relevant publicly available regulatory information provides insights and responds to consultations on proposed national regulatory guidance as appropriate and communicates final regulatory guidance for awareness and impact assessment in cooperation with Global Regulatory Policy.

Advocates for therapeutic areas/local positions on regulatory issues and trends internally (cross-functional internal business partners including GCTO market access policy etc.) and externally (Agency Industry Association) contributing to a broader policy platform and through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with our companys interests.

Shapes the regulatory environment through liaising with the local agency local pharmaceutical organization and other stakeholders and in concurrence with the EU Regulatory Policy lead.

Participates in internal regulatory policy managers meetings at sub-regional and regional level and related regulatory workgroups on selected issues.

For new regulations identifies and tracks changes/trends that might impact our companys business.

Participates in task forces of Pharmaceutical Industry/Agency.

Manage direct report

Sets up priorities organizes oversees and monitors direct reports activities towards divisions and countrys objectives achievement in compliance with policies and standards.

Ensures that direct reports are trained for their proper use of internal regulatory systems.

Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations requirements on Regulatory.

Manages coaches and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas of our companys.

Fosters a positive team spirit of the staff.

LOCAL REQUIREMENTS

Ensures handling of customer complaints distribution deviations and product recalls according to our companys standards and local procedure. Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP) Customer Service and/or PhV QP at wholesaler/distributor/importer level and/or Management (Crisis) team.

Secures compliance with respect to product quality safety and Good Distribution Practices according to local requirements.

Shapes the quality environment through liaising with the local agency local pharmaceutical organization and other stakeholders and in concurrence with the Quality.

Acts as a contact point for quality issues for Local Regulatory bodies.

Pricing and Reimbursement

Active participation in local P&R teams for the development of pricing and reimbursement applications as well as complementary documentation being focused on Added Therapeutic Value to support best conditions to allow launching of products and subsequent annual reviews as well as avoiding potential restrictions due to new indications.

Qualifications Skills & Experience

• Must be hold a MS degree in pharmacy or other life science or equivalent.
• An approx. minimum of 7 years experience in a Registration Department or equivalent which should include dealing directly with regulatory Agencies. The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.
• 2 years of people management experience is priority.
• Ability to communicate well verbally and in writing is essential as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing spreadsheets database application and internet.
• Experience dealing with most aspects of registration and experience in supervising others. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client-oriented approach and work according to our companys leadership vision

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