Pl and di Regulatory Compliance Department Manager

5 days ago

Jeddah, Saudi Arabia Nahdi Full time

Manages PL and Direct Imports Regulatory department and all the related regulatory activities within (including but not limited to New product introductions, product lifecycle maintenance, regulatory compliance, internal & external stakeholders management)
In order to support PL and DI business with highest level of compliance and sustainable growth, works closely and pro actively with governmental bodies like SFDA with aim to fulfill Business and Regulatory requirements for PL and Direct Imports Department within Nahdi Medical Company.

**Accountabilities**
- Lead & build a strategic high level of communication and maintain a relationship internal and external with SFDA and government entities related to product and vendor registrations (Pharma and Front shop)
- Ensure long term relationship with SFDA and various departments related to the strategic direction of the company and commercial must win battles (MWB)
- Lead and Engaged the Internal stakeholders (CLT, Category Management, Business senior management that concerns) to have smoother product launches and following government regulation and standard.
- Delivering NPD (New product development) registration timeline on time in full and continuous improving of timelines efficiency
- Manage the visit to SFDA frequently to ensure the smoother registration and provide any other necessary requirement (if needed)
- Understands the regulatory landscape in KSA. Monitors the regulatory environment and provides assessment of the impact of new and changing regulations on the company’s areas of interest.
- Responses to regulatory bodies inquiries (e.g. SFDA) and manages other correspondence in accordance with regulatory guidelines
- Manages and plans internal and external resources related to submission of various type of registration with SFDA and other stakeholders
- Supports PL and DI business by assessing opportunities for New Product Introduction
- Manages PL regulatory team and ensures continues development of talents
- Manages activities at a departmental level to fulfill both short & long term functional and business objectives.
- Communicates information and presents status updates on product/project(s) to key internal/external stakeholders when requested.
- Ensures SOP and SLAs related to Department are in place and up to date
- Manages external consulting agencies to ensure that appropriate standards and timelines are met.
- Manages allocated registration and 3rd party budgets (OPEX)

**Department Management**:

- Develop the department’s KPIs through the cascading of the division’s SMART objectives and monitoring the implementation to ensure the achievement of the set KPIs.
- Manage the department’s performance through providing performance feedback, conversations, appraisals, coaching, knowledge transferetc. to ensure the achievement of the set objectives and employees’ career development.
- Manage and develop the department SOPs, policies, procedures, processes, structure and SLAs to ensure the effectiveness and standardization of the department’s operations.

Employee duties are not limited only to the above-mentioned Accountabilities; he/she may perform other duties as assigned.

**Work Environment**
- Indoors : 80 %
- Outdoors : 20 %
- Working Days : 5 Working Days
- Days off : 2 Days Off
- Working Hours : 8:00 AM - 6:00 PM (1 hour break)

**Job Requirement**

Education
- BSc with Pharmaceutical or Medical background

Experience
- Min 8 years of Regulatory Affairs experience, must is experience working within Drugs and Health/Herbal sector
- Good communication skills, analytical, good knowledge of pharmacopoeias.
- Familiar with regulatory framework in KSA related to SFDA for different health practices; regulatory affairs & registration, export-import/clearance procedure, experienced with diverse sectors i.e. Pharma, Food, Medical devices
- Familiar with global standards of registration dossiers and other technical provisional file supportive elements, such as e-CTD, cGMP, Pricing, CPPs/FSCs, Conformity Bodies. Pharmaceutical market understanding is an advantage

Computer Skills
- MS Office Suite

Language
- English
- Arabic

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