Regional Regulatory Affairs Manager

Location: Singapore
Contract Type: Permanent
Specialisation: Supply Chain & Procurement
Salary: Negotiable
REF: BBBH238706_1574761135

Regional Regulatory Affairs Manager

A Pharmaceutical company based in Tuas is looking for a Regional Regulatory Affairs Manager to join their team. You will be accountable for creating the post approval submissions for Drug Products for country acceptability in terms of content, according to local regulations and requirements for assigned markets.

Your main responsibilities will be:

  • Coordinate & manage post approval submissions including Marketing Authorization Transfer (MAT) for a small group of assigned market(s)
  • Develop & manage post approval including MAT plan, strategy, timelines and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labelling team, Submissions Management, CMC, PV, Quality) to ensure a submission ready dossier for the assigned market(s).
  • Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
  • Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners
  • Capable of authoring some local submission components in relevant databases
  • Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
  • Liaise with the manufacturing sites for obtaining supporting documents as needed
  • Participate in local and regional regulatory initiatives promoting a culture aligned with the values and which supports compliance, innovation and talent development and retention.
  • Assist in ensuring internal regulatory processes and procedures are well documented.
  • Understand local regulations and trends for assigned markets, as communicated by the PCO.

Ideally you would Bachelor's degree or equivalent in Chemistry, Pharmacy, or a related life science. Minimum 5 years of experience in regulatory affairs, preferably in human medicines. Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards. Regional Regulatory experience including knowledge of ANDA, MAA submission processes and Product lifecycle management processes. Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.

If you believe you fit the requirements for the role, please click APPLY NOW. Alternatively, you can email your CV to #LI-NME

Data provided is for recruitment purposes only. Business License Number: 10C5117. EA Registration Number: R1544135 - Regrettably, only shortlisted candidates will be notified.