Regulatory Affairs Manager.

integratedresourcesinc
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📍 Lexington📍 Lexington, MA, United States📍 MA📍 usFull time

About this role

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

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.

Qualifications

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.

Additional Information

Kind Regards,

Sasha Sharma

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - 732-662-7964

Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs Manager. position at integratedresourcesinc?
The salary for this Regulatory Affairs Manager. role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Manager. position at integratedresourcesinc located?
This Regulatory Affairs Manager. role at integratedresourcesinc is based in Lexington, Lexington, MA, United States, MA, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Manager. role at integratedresourcesinc full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs Manager. role at integratedresourcesinc.
How do I apply for the Regulatory Affairs Manager. position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Affairs Manager. job at integratedresourcesinc posted?
This Regulatory Affairs Manager. position at integratedresourcesinc was posted on Jan 10, 2017. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Manager.
integratedresourcesinc
Apply for this role ↗

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