This is a Contract Role under Manpower Middle East - Tenure: 6 months

The Regulatory Specialist will be responsible for supporting AfME Regulatory Business Operations Specialist to deliver regulatory projects (Dossier Conformance Program & PEARL Remediation) and initiatives for Client’s markets in AfME region falling under the Client''s Established Products (PEH) business unit. The Regulatory Specialist will also provide internal support to AfME Regulatory Colleagues (CRL’s and RRL’s) as well as to the Life Cycle Management Team as needed.
The main focus of work will be the Dossier Conformance Program & PEARL Remediation in AfME region and other WSR projects as needed. In each case, the colleagues role is to support the AfME Regulatory Business Operations Specialist’s efforts to deliver project work in scope, within the time provided for the aforementioned projects which includes but is not limited to:

Dossier & Data Collection for products in scope
• Collating Module 3 dossier and/or subsections and documentation from a collection of post approval change submissions either electronically or hard copies, technically able to identify different parts of the dossier
Gap Analysis Support
• Assist and provide analysis, for Project Team Leads to review potential gaps in for sections of dossiers and licenses in scope, identified by a centralized team, from all AFME markets
• Assisting Project Team Leads regarding characterization of potential gaps so they may work with local market Regulatory to note time lines for gap closure
Gap Closure Support
• Provide knowledge on AfME market requirements; for Project Team Leads to take forward regarding any Gap Closure remediation activities.

Primary Responsibilities
Regulatory Remediation & Compliance:
- Engage and perform Remediation Plans assigned, involving cross-functional teams of AFME region.
- Ensure gaps in regulatory systems and processes are closed in order to improve deliverables and performance metrics of the AFME regulatory team.
-Provide support to the AfME Regulatory Business Operations Specialist to facilitate achievement of regulatory remediation objectives.
- Ensure adherence to quality and consistency of RA regulatory compliance activities in AFME as per the implementation of processes, policies, metrics and appropriate training.
- Responsible for compliance of the AFME regulatory data which is reflected in reports as ROOT, Viewpoint, and PEARL.
- Provide support to the AfME Regulatory Business Operations Specialist to facilitate achievement of regulatory compliance objectives.
- Provide Support to RRLs by ensuring upload of dossiers to documentation repositories and systems as needed.
- Responsible for enabling delivery of Regulatory Remediation and Compliance related projects by Project Team Leads to achieve the AFME region objectives.

Technical Skill Requirements
Key Characteristics
o Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner
o Quality Focus
o Detailed oriented
o Problem solving
o Effective Communication
o Team Player
o Outward looking
o Country/regional knowledge
o Negotiation skills
o Influencing
o Project management skills
o Change agile

Qualifications (i.e., preferred education, experience, attributes)
Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences

Main Skills
This is a Contract Role under Manpower Middle East - Tenure: 6 months The Regulatory Specialist will be responsible for supporting AfME Regulatory Business Operations Specialist to deliver regulatory projects (Dossier Conformance Program & PEARL Remediation) and initiatives for Client’s markets in AfME region falling under the Client''s Established Products (PEH) business unit. The Regulatory Specialist will also provide internal support to AfME Regulatory Colleagues (CRL’s and RRL’s) as well as to the Life Cycle Management Team as needed. The main focus of work will be the Dossier Conformance Program & PEARL Remediation in AfME region and other WSR projects as needed. In each case, the colleagues role is to support the AfME Regulatory Business Operations Specialist’s efforts to deliver project work in scope, within the time provided for the aforementioned projects which includes but is not limited to: Dossier & Data Collection for products in scope • Collating Module 3 dossier and/or subsections and documentation from a collection of post approval change submissions either electronically or hard copies, technically able to identify different parts of the dossier Gap Analysis Support • Assist and provide analysis, for Project Team Leads to review potential gaps in for sections of dossiers and licenses in scope, identified by a centralized team, from all AFME markets • Assisting Project Team Leads regarding characterization of potential gaps so they may work with local market Regulatory to note time lines for gap closure Gap Closure Support • Provide knowledge on AfME market requirements; for Project Team Leads to take forward regarding any Gap Closure remediation activities. Primary Responsibilities Regulatory Remediation & Compliance:  Engage and perform Remediation Plans assigned, involving cross-functional teams of AFME region.  Ensure gaps in regulatory systems and processes are closed in order to improve deliverables and performance metrics of the AFME regulatory team. Provide support to the AfME Regulatory Business Operations Specialist to facilitate achievement of regulatory remediation objectives.  Ensure adherence to quality and consistency of RA regulatory compliance activities in AFME as per the implementation of processes, policies, metrics and appropriate training.  Responsible for compliance of the AFME regulatory data which is reflected in reports as ROOT, Viewpoint, and PEARL.  Provide support to the AfME Regulatory Business Operations Specialist to facilitate achievement of regulatory compliance objectives.  Provide Support to RRLs by ensuring upload of dossiers to documentation repositories and systems as needed.  Responsible for enabling delivery of Regulatory Remediation and Compliance related projects by Project Team Leads to achieve the AFME region objectives. Technical Skill Requirements Key Characteristics o Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner o Quality Focus o Detailed oriented o Problem solving o Effective Communication o Team Player o Outward looking o Country/regional knowledge o Negotiation skills o Influencing o Project management skills o Change agile Qualifications (i.e., preferred education, experience, attributes) Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences