Senior CMC Regulatory Affairs Consultant Biologics Remote

Parexel; Honolulu (HI); A distancia; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel in the United States (remote) seeks a Senior Regulatory Affairs Consultant – CMC Biologics to drive regulatory strategy for biologics and small molecules across development stages, supporting FDA, EMA, and Health Canada submissions. This role collaborates with manufacturing, quality, and project teams, develops CMC strategies, ensures GMP compliance, and participates in health authority meetings.

A strong regulatory background and 7+ years in pharmaceutical development are expected.

Formación

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience with regulatory filing history.
• Experience with IND, NDA, DMF submissions for FDA/Europe/Canada.
• Strong analytical and communication skills.

Responsabilidades

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and coordinate CMC and GMP submission documents.
• Collaborate with manufacturing, quality, and project teams.
• Support health authority meetings and post-approval changes.
• Represent CMC regulatory affairs in cross-functional teams.

Conocimientos

Regulatory affairs

CMC Biologics

Biopharma development

Project management

MS Office

Educación

Pharmaceutical Sciences / Chemistry / Pharmacy (Bachelors or PharmD)

Herramientas

CREDO

ORIOM

TrackWise Digital

TRS Viewer

Descripción del empleo

Parexel in the United States (remote) seeks a Senior Regulatory Affairs Consultant – CMC Biologics to drive regulatory strategy for biologics and small molecules across development stages, supporting FDA, EMA, and Health Canada submissions. This role collaborates with manufacturing, quality, and project teams, develops CMC strategies, ensures GMP compliance, and participates in health authority meetings.

A strong regulatory background and 7+ years in pharmaceutical development are expected.