Direct Hire - Senior Manager, CMC Regulatory Affairs job Raleigh North Carolina
Direct Hire - Senior Manager, CMC Regulatory Affairs job Raleigh North Carolina
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Direct Hire - Senior Manager, CMC Regulatory Affairs Job



Employer Name: SpiderID: 7858289
Location: Raleigh, North Carolina Date Posted: 8/15/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27248

Job Description:

Job Summary



  • Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific background within this human health care pharmaceutical company.


Responsibilities



  • Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk.

  • Prepares original NDAs, MAAs and Growth Market dossiers ensuring that quality documents are prepared.

  • Tracks Module 3 leafs for global submissions.

  • Leads CMC authoring kick off meetings.

  • Interacts with and influences external stake holders.

  • Develops regulatory strategy.


Post Approval Projects



  • Prepares CMC content of post approval supplements and variations globally; annual reports, product renewals, notifications and change supplements.

  • Tracks Module 3 leaf changes made as a result of post approval activity and submissions.

  • Leads CMC authoring kick off meetings. Guides authors regarding the necessary Module 3 updates.

  • Interacts with and influences external stakeholders.

  • Evaluates proposed post approval changes and develops the regulatory strategy.

  • Maintains Agency Approved Module 3 dossiers globally.


Qualifications
Education/Experience



  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with minimum 4-6 years of experience in the pharmaceutical industry

  • Knowledge and experience of CMC activity in medicine development and post approval management. Knowledge of health authority guidance and regulations.


Skills



  • Skills to drive and navigate project

  • Knowledge of CTD dossier (module 2.3 and 3).

  • Strategic business thinking

  • Global organizational awareness

  • Excellent written and verbal communication skills

  • Leading change/innovative thinker




Please submit your resume for consideration. Once submitted, feel free to contact Rushi at 858-703-6733 for additional information.

Approx. Duration: Perm

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

As the staffing industry evolves, Hired by Matrix continues to develop and grow. By combining our expertise with a keen understanding of each client's needs we are able to source for the most qualified candidates. Our commitment to servicing our clients corresponds with our commitment to finding the perfect match between our clients and candidates and maintaining our relationships long term.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

Connect with us on LinkedIn and see how we can impact your career!
Hired by Matrix Career Center: http://bit.ly/HbMCareers



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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