20 days old

Director Regulatory Affairs

West Chester, PA 19380
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

Summary

The Director, Regulatory Affairs is primarily responsible for review of FDA submissions and internal documents, FDA contacts, regulatory strategies, and supervision/training of direct reports.

Essential Duties:                 

 
1.Primary FDA contact on behalf of Teva Global Respiratory, Regulatory Affairs.  
2.Review outgoing FDA correspondence and content (BLAs/NDAs, amendments, annual reports, supplements) for completeness and correctness.                               
3.Review incoming FDA correspondence, determine its distribution, and initiate appropriate response where applicable.                                                                          
4.Develop and communicate regulatory strategies to internal customers.          
5.Supervise and train direct reports, conduct performance evaluations, dispute resolution, etc.                                                                                                            
6.Up to 20% travel                                                                                                       

 

Primary Outcomes


Obtain approval of BLAs/NDAs and supplements.
Meet submission goals for new IND, BLA/NDA and other FDA filings.
Maintain INDs and approved BLAs/NDAs in compliance with FDA regulations.
Provide appropriate advice to internal customers.
Supervise/train direct reports to improve their knowledge and performance.

Qualifications

Education Required:  Minimum BS degree in scientific or healthcare discipline, equivalent combination of education and related experience.

Education Preferred: R.PH., Pharm.D, M.S., Ph.D., or equivalent, combination and related experience.

Experience Required:  Minimum 7 years in pharmaceutical regulatory affairs with emphasis on CMC, Development, or equivalent.

Experience Preferred: 3+years in a supervisory position.

Specialized or Technical Knowledge: R.Ph., and/or RAC certification is preferred

Licenses, Certifications: BLA/NDA submissions and approval requirements preferred, working knowledge of chemistry, manufacturing and controls as needed for NDA submissions. desired

Technical: Demonstrates advanced understanding of R&D processes required for BLA and/or NDA submissions.

Problem Solving:  Demonstrates advanced ability to respond to FDA deficiencies in a manner acceptable to both FDA and affected Teva departments.
 Demonstrates advanced judgment in determining whether a BLA/NDA is sufficiently complete to be accepted for filing by the appropriate FDA Division or Office, or will be refused.

 

Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
In process of validation
Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-09-30 Expires: 2019-11-03

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Director Regulatory Affairs

Teva Pharmaceuticals
West Chester, PA 19380

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