2018-09-17

Senior Manager CMC Regulatory Affairs
Job Opportunity at Clinical Dynamix, Inc.

Posted on Sep 17

http://www.clinicaldynamix.com    561-732-4505

Location: Cambridge, MA
Job Type: Full Time
Job ID: W4166161

High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC

Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines. 
 
 
Summary of Key Responsibilities:
  • Responsible for preparation of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management
  • Prepare regulatory submissions that involve CMC components including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates.
  • Work cooperatively with colleagues in applicable expertise areas (Process Development, Analytical Development, Manufacturing, Supply Chain, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of Alnylam’s objectives relating to the preparation of CMC regulatory submissions and associated activities
  •  Actively participate in RA CMC infrastructure and capability building.  Assists in the development and implementations of departmental processes, procedures and policies
 
 

 
Qualifications:
  • BS in science related field required, MS/PhD preferred
  • Minimum 5 years (with BS) of technical writing experience in the pharmaceutical/biotechnology/life science industry.
  • Detail oriented and articulate with ability to write in a precise, clear style.
  • Sound understanding of chemistry and basic knowledge of molecular biology. Experience in oligonucleotide is a plus.
  • Direct experience in preparation of original NDA/BLA, response to regulatory agency queries, and/or other complex submissions
  • Expertise in CMC with an understanding of phase-related expectations throughout the lifecycle of drug development.
  • Strong interpersonal skills and ability to collaborate effectively with various technical area experts within the company and with alliance partners.
  • Excellent written and communication skills.
  • Drive and energy to work on multiple projects in a fast-paced environment, with flexibility and strength to navigate through high stress situations.
  • Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
  • Knowledge and understanding of US, EU, Canada, and ICH guidelines and understanding of international CMC requirements.
  • Highly computer literate (Word, Excel, PowerPoint).
  • Facility and familiarity with constructing, compiling, reviewing and maintaining regulatory submissions in accordance with eCTD requirements.
 



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