regulatory affairs manager in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
reference number
90M0341400_1522200190
contact
jin quan jonathan soh, randstad
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job description

Key Responsibilities

  • Timely management of the registration activities including technical variations and labelling updates
  • Work closely with the team and above country regulatory colleagues for prompt response to regulatory queries
  • Handle the regulatory activities on labelling updates, pack changes, artwork development, proof reading and approval of artwork in line with registered details
  • Build effective working relationships within regulatory team and other relevant local stakeholders
  • Comply with local, regional and corporate regulatory SOPs and other processes
  • Support other regulatory activities such as local and central compliance activities, product licences activities, due diligence checks

Role Requirements
To be successful in this role, you must have the technical and clinical knowledge of pharmaceuticals gained from your academic, pre-registration training and your experience in Regulatory Affairs. You must be able to work with minimum supervision and work under pressure.

A fast expanding biotech company is looking for a Regulatory Affairs Manager. The Regulatory Affairs manager will be required to support the business in Singapore by handling product registrations and maintaining product life cycle for pharmaceuticals and vaccines. You will also be required to support regulatory initiatives and processes in line with local and corporate requirements.

Basic qualifications:

  • Bachelors degree in pharmacy
  • Registered Pharmacist in Singapore
  • Pharma industry experience in a similar role supporting regulatory affairs is a must
  • Preferred Qualifications
  • Strong ability to work in a fast paced environment
  • Strong interpersonal skills
  • Attention to detail



To apply online please use the 'apply' function, alternatively you may contact Jonathan Soh at 6510 6514.
(EA: 94C3609)