Associate Director, CMC Regulatory Affairs

Role Summary

Associate Director, CMC Regulatory Affairs responsible for leading global regulatory submissions, responding to deficiency letters, and guiding regulatory strategies for health authority interactions.

Responsibilities

• Lead and compile global regulatory submissions using eCTD.
• Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input on interpretation and formulation of responses.
• Assist with development of documents submitted to health authorities and related to expedited regulatory programs, meeting requests, background packages, and other regulatory documents.
• Author internal regulatory documents, such as Regulatory Assessments and Strategy documents.
• Review internal change controls and assess impact to regulatory filings.

Qualifications

• Required: Pharm.D or Ph.D. in Regulatory Affairs, Life Sciences, or related field, or foreign equivalent.
• Required: 5 years of experience in the offered position or related role.
• Required: At least 5 years of experience with analysis and interpretation of complex problems and data in regulatory affairs.
• Required: At least 5 years of experience with global regulatory guidelines (U.S., LATAM, EMEA, APAC) and related regulations/requirements.
• Required: At least 5 years of experience working with small molecule/biologics.

Education

• Pharm.D or Ph.D. in Regulatory Affairs, Life Sciences, or related field (or foreign equivalent).

Additional Requirements

• Location: Danbury, CT (as stated in description).