4 days old
2017-12-072018-01-05

Manager or Sr. Manager, Regulatory Affairs CMC - Specialty Products - Biologics

Teva Pharmaceuticals
Reston, PA
  • Job Code
    17-20190
Careers - Teva Pharmaceuticals in the US -Manager or Sr. Manager, Regulatory Affairs CMC - Specialty Products - Biologics

Manager or Sr. Manager, Regulatory Affairs CMC - Specialty Products - Biologics

US-PA-Frazer
Requisition #
17-20190
# Positions
1
Experience (Years)
4
Category
Regulatory Affairs - Regulatory Affairs

Overview

 

Teva Pharmaceuticals' Global Regulatory Affairs team has a new opportunity for a  Manager or Sr. Manager CMC Regulatory Affairs to support our expanding Specialty Products - Biologics portfolio.   This role will be located at our Frazer, PA site. 

 

The Manager CMC, Regulatory Affairs (Specialty Products - Biologics) will be responsible for developing, coordinating, and supporting the CMC aspects of regulatory submissions to global Health Authorities for specialty development products and in support of marketed product registrations.

 

The Senior Manager CMC, Regulatory Affairs (Specialty Products - Biologics/Biosimilars) will be responsible for developing, coordinating, and supporting the CMC aspects of regulatory submissions to global Health Authorities for new specialty products and marketed product registrations as well as licensing opportunities. The Sr. Manager may also be required to serve as the global regulatory project leader (GRPL).

 

Responsibilities

• Leads and implements regional and/or global CMC strategy & submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs/ BLAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products

 

• Supports internal interactions (Manager) or interfaces with (Sr. Manager) Health Authority project managers and CMC reviewers to facilitate approval of regulatory submissions and coordinates responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues.

 

• The Manager arranges for, coordinates and supports the team in planning, preparation, and execution of meetings or teleconferences with Health Authorities (e.g., FDA, EMA). The Sr. Manager arranges for, coordinates and leads the team in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA).

 

• Represents regulatory CMC and provides US regulatory filing strategy recommendations to interdisciplinary project teams. Facilitates (Manager)/coordinates (Sr. Manager) global regulatory strategy development with relevant groups to ensure consensus on critical issues, and identification and communication of regional differences including implementation plans.

 

 

 

Qualifications

  

Education:

 

Bachelor’s Degree in scientific field, such as biochemistry, biotechnology, cell biology or similar.     PharmD, Ph.D., or Master’s degree pred.

 

Experience Required:

  • Manager:  4-8 years, Sr. Manager: 7+ years (or equivalent combination of education and related work experience) of biopharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of U.S. laws and FDA regulations / guidance applicable to registration and approval of drugs or biologics.
  • Working knowledge/experience in regulatory submissions and approval processes for Biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements

 

Experience Pred: 

  • 6 plus years (Manager)/8 years (Sr. Manager) in regulatory affairs with proven experience in successful filing and defense of major submissions -- IND / NDA / BLA / CTA / MAA.  Strong background in biopharmaceutical development with focus on CMC aspects
  • Manager:  Working knowledge of principles embodied in ICH Guidances Q8, 9, 10, including QbD
  • Sr. Manager:  Experience implementing principles embodied in ICH Guidances Q8, 9, 10, including QbD
  • Sr. Manager:  2 -4 years management experience

 

Specialized or Technical Knowledge needed: 

  • Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines, GCPs, GMPs, GLPs.

 

  

#LINKEDIN

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Connect With Us!

Not ready to ? Connect with us for general consideration.

Categories

  • Biotechnology / Science
  • Marketing

Share this job:

Manager or Sr. Manager, Regulatory Affairs CMC - Specialty Products - Biologics

Teva Pharmaceuticals
Reston, PA

Share this job

Manager or Sr. Manager, Regulatory Affairs CMC - Specialty Products - Biologics

Teva Pharmaceuticals
Reston, PA

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast