Regulatory Affairs Project Manager

Job Description:

• Evaluate the impact of clinical/regulatory changes on assigned projects as well as reputed company business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval reputed company project timelines
• Monitor project schedule and scope to ensure both remain on track
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both reputed company and client requirements
• Propose and implement improvements to enhance efficiency and quality of the work performed on assigned projects

Requirements:

• University/college degree (life science preferred) or certification in a reputed company allied health profession (i.e. nursing, medical or laboratory technology)
• Understanding of governmental regulatory processes and regulations as pertains to drug regulation
• Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
• Working knowledge of project management processes, especially as it relates to clinical development
• At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
• Fluent in local office language and in English, both written and verbal

Benefits:

• Medical, Dental, Vision, Life, STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable

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