Associate Principal Scientist (assoc. Director), Regulatory Affairs - Cmc

Laboratory Animal Management Association

Multiple Locations
Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Cmc regulatory strategies
Small molecule respiratory/inhalation products
Preparation and submission of cmc dossiers
This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance’s, with a focus on small molecule respiratory/inhalation product development

Job Summary

  • This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance’s, with a focus on small molecule respiratory/inhalation product development.
  • Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
  • The salary range for this role is $142,400.00 - $224,100.00; The successful candidate will be eligible for annual bonus and long-term incentive, if applicable; We offer a comprehensive package of benefits.

Matching Summary

This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance’s, with a focus on small molecule respiratory/inhalation product development.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • CMC regulatory strategies
  • small molecule respiratory/inhalation products
  • preparation and submission of CMC dossiers
  • regulatory CMC experience
  • global regulatory guidance's
  • critical thinking capabilities

Nice-to-have

  • innovative and imaginative approaches
  • rapid, disciplined decision making
  • excellent interpersonal skills
  • proven record of working with teams
  • additional language skills

Key Requirements

  • 5+ years of relevant experience
  • B.S. in biological science, engineering, or related field
  • Regulatory CMC experience with inhalation products
  • Proficient in English

Work Rights

Not specified

Tailored Resume

Cover Letter