Manager Regulatory Affairs-CMC

Job Title: Manager Regulatory Affairs-CMC

Location: Lexington, MA
Duration: 4+months (Possibility of extension)

Business Function: R&D
Department Name: Global Regulatory Affairs

Primary Role:

Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions.

Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives.

Responsibilities:

50% of the time develops global CMC Core Dossier for Module 2.3 and Module 3 CTD sections

50% of the time prepares CMC components of new Marketing Authorization Applications for international countries

EDUCATION & EXPERIENCE
Requirements:

Bachelor’s degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.

Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics/small molecule drug development and registration activities.

Key Skills and Competencies:

Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement

Ensures timely delivery of high quality regulatory submissions

Must be highly organized, committed to excellence, and possess both determination and attention to detail.