We are looking for Regulatory Affair Manager (Labelling) x 1 Vacancy who taking care of labelling process and report to Global Labelling Manager.
The salary is up-to 150K + benefits
Key responsibilities for this role include:
- Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
- Reports on agreed key performance indicators for set region.
- Onboards and manages regional assigned labelling associates.
- Communicate clearly issues and resolutions to peers and subordinates in a meaningful way.
- Ensures local labelling text is prepared right first time and on-time according to agreed company procedures and objectives.
- Supports regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission.
- Advises Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
- Ensures that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation
- Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation.
- Manages all labelling variations through the Regulatory Information Management System and Track wise Change control environment as needed to show compliance to global submission timelines and valid reason for delay.
- Liaises with Translation vendors as needed.
- General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
- Ensures maintenance of relevant systems according to relevant SOPs.
- Ensures compliance with all relevant company SOPs
- Provides support during Medical and Regulatory Audits.
- Performs other duties as assigned.
Qualifications & competencies for this role are:
- We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Science, Medicine or Pharmacy, or another related field
- Labelling and Regulatory experience
- Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge
- Highly developed interpersonal, presentation and communication skills with advanced English language capability
- If you have the following characteristics, it would be a plus:
- Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
- Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
- Understand GLC requirements/ processes and EU/ US regulatory requirements.
- The ability to influence effectively in a matrixed, cross functional team environment
Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.