Regulatory Affairs Pharmaceutical Consultants

  • Anywhere
  • Posted 6 months ago

Lachman Consultants

Lachman Consultants is in need of Per Diem Pharmaceutical Regulatory Affairs Consultants with comprehensive expertise in U.S. FDA pharmaceutical industry regulations and guidances. Must have demonstrable, hands-on experience from working in a Regulatory Affairs Department in the following areas:

• Familiarity with FDA regulations and guidance

• Experience responding to FDA Information Requests and Complete Response Letters

• Experience with transdermal, foam and semi-solid dosage forms a plus

• Experience with preparing eCTD submissions a plus

• Experience providing regulatory assessments of postapproval changes

• Experience providing strategic regulatory advice in support of DMFs, INDs, NDAs, ANDAs, and BLAs

Consultants must have a minimum of a Bachelor’s degree in life sciences, engineering or related field and 10 years’ related experience, as well as detailed knowledge of current FDA regulations and expectations. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly. If you meet all of the qualifications, please submit your full chronological resume via the Lachman website or to recruitment@lachmanconsultants.com. No phone calls please. Thank you.

Upload your CV/resume or any other relevant file. Max. file size: 50 MB.