Regulatory Affairs Expert/ Senior Specialist

4 weeks ago

Jeddah, Saudi Arabia Novasyte Full time

Essential Functions Regulatory Role
- Act as a Regional Regulatory affairs lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Saudi and /or South Africa region

Act as client’ representative in front of health authorities SAHPRA and/or SFDA and with t client partner (Agents/distributes) in several countries.

Scope of countries for the role based in south Africa is: South Africa, Namibia and Botswana

Scope of countries for the role based in Saudi is: Saudi Arabia and GHC mainly. Gulf experience is a plus. (Kuwait, Bahrain, Oman, Qatar, UAE)
- Prepare, review and submit regulatory documentation (for example: CTD/eCTD submissions), as appropriate; follow through post approval commitments.

Meet with Officials in Health authorities were applicable and represent the client.
- Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments.
- Act as a Subject matter expert implementing Regulatory knowledge for post marketing approvals and well-established marketed products in Medical device, pharmaceutical and Biological innovative products in, Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Complex cross country change assessments/Market authorization approvals/ Gap analysis and assessments safety variations and manufacturing site renewals or as applicable.

Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.

Update client regulatory compliance systems and ensure following the metrics and SOPs

Support pricing reg-intal in the country and provide advice as needed, prepare pricing submission packages as required and based on client request and variation requirements.
- Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate.
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding
- May present to clients on complex regulatory processes at large full-service bid defense meetings; and preparation for new opportunities.

Network with clinical operation, IMS and business development and other cross-functional teams in additional to maximize external networking with potential clients and stakeholders to identify potential opportunity and bring more business.
- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
- Performs other tasks or assignments, as delegated by Regulatory management.

Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement as needed.

May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed - Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific improvement initiatives.
- Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role. ;

**Qualifications**:

- Degree in pharmaceutical science is a must. Professional post graduate degree is a plus

High English proficiency, French proficiency is a plus
- for the senior specialist role: At least 3-5 years relevant experience in regulatory national and/or regional scope of work in saudi and/or GCC. (For Saudi role). South Africa and west African countries for the South Africa role
- for the Manager role: At least 5-7 years relevant experience in regulatory national and/or regional scope of work in Saudi and/or GCC. (For Saudi role). South Africa and west African countries for the South Africa role
- Good understanding of the regulations and related guidelines in Saudi/gulf and (or) north /west Africa region
- Good understanding of Regulations (Pharmaceutical and Biological is a must).Medical device is a plus

This is for both generic and innovative medicine
- Good knowledge of different regulatory dossiers : CTD, e-CTD, NeeS,..is a must.

Capacity to read and understand high level SOPs, e-trainings, work easily on veeva and collaborate according to ways of work
- Possesses a specific regulatory and technical expertise;

Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good manufacturing Practice (GMP), applicable regulatory requirements,. Knowledge of National Regulations and (CMC).
- Knowledge of Pharmaceutical industry operations, the link of change controls to production and supply and SKU sharing
- Good, solid interpersonal communication and organization skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;

Strong software knowledge of finance and planning systems (oracle, SAP,). Strong knowledge

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