Regulatory Affairs Associate

Employment: Outsourced through Manpower Group

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.

• 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.

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

• 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.

• Support implementation of relevant internal regulatory initiatives.

• 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.

• 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.

• Associate

• Contract

• Quality Assurance and Other
• Pharmaceutical Manufacturing