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02 September 2019
Job ID: JKT-32212
International RA officer

 

Job Description:

 

As a regulatory affairs officer, you'll need to:

 

 

 

  • ensure that a company's products comply with the regulations of Vietnam

  • keep up to date with DAV, USFDSA, EMA, TGA and other international legislation, guidelines and customer practices

  • collect, collate, translate and evaluate scientific data from a range of sources

  • develop and write clear arguments and explanations for new product licences and licence renewals

  • prepare submissions of licence variations and renewals to strict deadlines

  • monitor and set timelines for licence variations and renewal approvals

  • advise headquarter or manufacturers on regulatory requirements

  • provide strategic advice to senior management throughout the development of a new product

  • project manage teams of colleagues involved with the development of new products

  • undertake and manage regulatory inspections

  • review company practices and provide advice on changes to systems

  • liaise with, and make presentations to, regulatory authorities, report to headquarter

  • negotiate with regulatory authorities for marketing authorization

  • work with specialist computer software and resources

  • write clear, accessible product labels and patient information leaflets

  • plan and develop product trials and interpret trial data

 

Skills

 

You'll need to have:

 

  • Good listening, speaking, reading and writing skills on English (or Chinese) and local language, able to read and translate drug administration/regulatory documents.
  • Bachelor degree or above in pharmacy or chemistry related major, with more than 5 years of drug registration experience, chemical drug registration program experience is preferred
  • Know well on DAV, USFDA, EMA, ICH etc. regulatory requirements and guidelines
  • team-working skills and the ability to lead and motivate others
  • analytical and problem-solving skills
  • strong negotiation skills
  • the ability to work under pressure and to strict deadlines
  • the confidence to report to management
  • project-management skills
  • integrity and a professional approach to work

 


Job Details:
  • Employment Type:
    Full Time, Part Time
  • Required Qualification:
    Degree
  • Required Experience:
    3 years
  • Job Functions:
  • Company Industry:
    Medical / Pharmaceutical
  • Location:
    Jakarta, Indonesia
  • Salary:
    Salary negotiable

Splendris Pharmaceuticals GmbH
http://www.splendris-pharmaceuticals.de/en/

Splendris Pharmaceuticals GmbH, founded in 2011, is an international company with a professional focus on the healthcare market.

Splendris Pharmaceuticals GmbH is focused in providing medicinal products for human health in the segments of:

Cardiovascular
Oncology
Diabetes
and Antibiotics