Regulatory Affairs Manager(Specialist)

1 month ago


raleigh, United States Advanced Recruiting Partners Full time

Responsibilities

  • The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs
  • Supports regulatory agency interactions, communications, and preparation of submissions
  • Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility
  • With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility
  • With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; contribute to global strategy via participation.
  • With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission
  • Provide updates to internal documentation, as appropriate
  • With guidance, provides support to GMP, GCP, and GPV inspections from health authorities
  • With guidance supports pre-approval and post-approval activities
  • With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners
  • With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution


Qualifications

  • At least 3 years of experience within Regulatory Affairs
  • Professional skills needed to hold the position:
  • General knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance
  • Effective in verbal and written communication
  • Able to work in a matrix and in multicultural teams
  • Result-driven
  • Listen, social intelligence, and diplomatic
  • Good knowledge of regulatory tools for tracking and archiving
  • Good knowledge of basic Office programs
  • Ability to prepare PowerPoint presentations
  • Ability to search and retrieve information from the worldwide web
  • University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
  • Scientific secondary-school diploma with at least 5 years of experience within International Regulatory Affairs
  • Written and spoken English



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