Regulatory Affairs Senior Specialist

3 days ago

Riyadh, Saudi Arabia MSD Full time

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

**Basic Functions & Responsibilities**:
**Essential functions include, but are not limited to**:
For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
For assigned products and tasks, stays updated on late pipeline filings, relevant regional 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.
Maintains a positive relationship with internal and external regulatory contacts.

**Applicable to incumbent with direct reports only**: Responsible for people management of applicable Regulatory personnel in Saudi Arabia and provides clear leadership.
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 include, but are not limited to**:
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.

**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.

**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 company local standards and 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 to generate mockup 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 completed.
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.

**Labeling and artwork**:
Ensures high quality translations and 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 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 group responsible for Clinical Trials.
Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as 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.
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 environment**:
Keeps abreast of local and international laws.
Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with our company interests.
Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and o

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