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Senior Director Regulatory Affairs - Women's Health, Respiratory & Oncology

Date: Jan 6, 2019

Location: Frazer, Pennsylvania, US, 19355

Company: Teva Pharmaceuticals

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

 The Sr. Dir. is responsible for providing regulatory direction and management for the global specialty development- projects and US marketed product supporting the Respiratory, Oncology and Women’s Health therapeutic area(s) (TA).  This includes developing, coordinating and executing regulatory strategies and guiding staff at all levels on appropriate regulatory strategies with respect to Nonclinical and Clinical aspects of the programs. The Sr. Dir. will create strong and effective relationships with other regional and functional regulatory peers and staff on the development of ex-US submission strategies and provide support as needed.  This role would represent Regulatory Affairs on needed therapeutic area cross-functional teams and provide oversight across the TA. The individual will interact with FDA and ex-US health authorities as needed and oversee maintenance activities for regulatory filings and ensure timely and high quality submissions.

It is the responsibility of the Sr. Dir. to recruit, retain, support, mentor and develop opportunities for staff.

Responsibilities:

  • Provide oversight to staff with respect to global regulatory strategies for each project within the Therapeutic area(s); ensure timely and high quality submissions; provide guidance and oversight for health authority interactions/meetings.
  • Understand and contribute scientifically to ongoing R&D projects
  • Directs the Regulatory Team efforts required for the submission of  INDs, CTAs, NDAs, sNDAs, BLAs and MAAs as well as related  supplements/variations and annual reports when necessary. Conduct gap analyses in a timely manner.  Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required
  • Interface with the FDA regarding pre-clinical and clinical development issues and provide support to our ex-US Regulatory counterparts regarding preclinical and clinical support, including the preparation of technical position papers, as needed.
  • Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
  • Coach and mentor staff in the performance of their duties.  Identify opportunities for enhanced efficiency of departmental activities.

    Provides regular and timely updates to Sr. regulatory management on the status of all pending applications and planned submissions as necessary
  • Manage budget to ensure the department meets agreed upon budget commitments 

 

 

Qualifications

Advanced Degree in scientific field or equivalent combination of education and related work experience

PharmD, Ph.D., MD

PhD + 5-7 years experience in pharmaceutical regulatory affairs

Or MS + 7-10 years experience in pharmaceutical regulatory affairs

Or BS + 10-15 years experience in pharmaceutical regulatory affairs

Knowledge of drug development process and global drug approval process,, regulatory requirements and health agency interactions

At least 7 years in regulatory affairs with proven experience (successful filing and defense of major submissions -- IND / NDA / BLA / CTA / MAA) setting and executing strategy in pre-clinical, clinical, CMC, or marketed products.

Additional 3-5 years management experience

Familiarity with international drug regulations

Additional experience with global submissions and international regulatory interactions

In-depth knowledge of FDA regulations regarding pre-clinical and clinical requirements

 

Excellent communication skills

Experience with IND, NDA and/or BLA filings. Experience with eCTD documentation.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Teva’s 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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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