Regulatory Affairs Associate

Manpower Middle East; Dubai; On-site; AED 180,000 - 360,000; Full time

Job summary

Manpower Middle East in Dubai is seeking an Affiliate Regulatory Affairs professional to execute regulatory operations, maintain licenses, prepare registrations and coordinate labelling activities in line with local MOH requirements. You will support regulatory plan execution, ensure timely submissions, manage administrative tasks, and maintain current product information and archives.

A Bachelor's degree in pharmacy or a related scientific field, solid IT skills and excellent English are

Qualifications

• Bachelor's degree in pharmacy or equivalent in a relevant scientific subject.
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English.
• Previous experience will be highly regarded.

Responsibilities

• Execute regulatory plan activities and maintain licenses and registrations.
• Support submissions of regulatory applications within planned timelines.
• Coordinate administrative tasks (translations, legalizations) to facilitate compliance.
• Maintain up-to-date regulatory archives and product information.
• Contribute to internal audits and keep regulatory IT tools accurate.
• Ensure products comply with local regulations and MOH requirements.
• Support labelling processes and eLabeling, ensuring correct Product Information.

Skills

English proficiency

IT skills

Teamwork

Education

Bachelor's degree in pharmacy or equivalent

Job description

Job Purpose:

The purpose of the Affiliate Regulatory Affairs role is to execute the operational aspects of regulatory affairs for the marketing affiliate, including:

• License maintenance activities (e.g. Labelling changes, CMC Changes, Renewals)
• New registrations, line extensions and new indications.
• Tracking regulatory procedures and archiving correspondence in accordance with local regulations and quality system requirements.

• Provide operational excellence to successfully achieve Affiliate regulatory objectives.
• Facilitate and cultivate relationships with relevant external regulatory personnel

Regulatory Plan Execution

• Collaborate with the implementation of the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
• Support submission of high quality regulatory applications within planned timelines.
• Support dossier preparation of new applications to obtain marketing authorizations.
• Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate
• Execute maintenance activities for marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports).
• Support Dossier assembly in compliance with local regulations and quality system requirements.
• Maintain awareness of current regulations and upcoming changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.

Regulatory Compliance

• Keep internal Regulatory IT tools up to date and accurate
• Ensure that all products comply with local regulations and quality system requirements

whichever is more stringent.

• Keep the regulatory archive complete and up-to-date and ensure that all current licenses

and labels are readily available

• Support implementation of local quality system in line with the global quality system and

local regulations.

• Support internal audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.

• Raise awareness on compliance issues with leadership and relevant functions.

Labelling

• Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
• Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labeling
• Ensure the effective execution of eLabeling and the maintenance of correct Product Information on the eLabeling website.

Process Improvement

• Support implementation of relevant internal regulatory initiatives.

Personal and Professional Development

• Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
• If available, attend external regulatory training or MoH meetings focusing on local regulations
• Bachelor's degree in pharmacy or equivalent in a relevant scientific subject
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English.
• Previous experience will be highly regarded

Other Information/Additional Preferences:

• Ability to adapt to difficult and different challenges.
• Team working skills with special focus on results.
• Good capability to establish positive networking both internally and externally