Regulatory Affairs Manager.

Job Description:

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

• Someone who can review the current NDA.

Requirements:

• Bachelor’s degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.( Pharma/Biotech is a Must Have)

• Need 5-8 years of experience with Global Submissions (US and European Knowledge) required

• Actively involved in writing or reviewing applications to understand what content is required.

• Must have Regulatory CMC Experience (5-8 years) .

• Must have knowledge of BLA or NDA.

• Cannot come directly from Education.

• Know content module 2-3 for CMC.

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.

Kind Regards,

Sasha Sharma

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - 732-662-7964