Regulatory Manager

Employer
Location
Rockville, Maryland
Posted
Apr 13, 2017
Closes
May 18, 2017
Function
Management, Other
Hours
Full Time

Job description:

  • Maintaining, managing and improving GMP facility with the help of senior GMP consultant;
  • Ensuring compliance with regulations set by the Authorities
  • Providing advice about regulations to manufacture team
  • Planning, undertaking and overseeing product development and regulatory inspections
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Offering advice about company policies, practices and systems
  • Obtaining marketing permission
  • Liaising and negotiating with US and international regulatory authorities
  • Ensuring that quality standards are met and submissions meet strict deadlines
  • Preparing documentations

Requirements:

  • Relevant degree such as biotechnology, biomedical science et al.
  • Good communication skills
  • Good interpersonal skills
  • Excellent language skills
  • Related work experiences preferred.

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