1+ months

Senior Manager Regulatory Affairs

Frazer, PA 15084
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

Position Summary:

The Global Specialty Regulatory Affairs (GSRA) group is a global department that plays a crucial role in TEVA Specialty Research & Development organization, a highly regulated environment. Within GSRA, the Respiratory and Oncology team is responsible for the global regulatory strategy of an impressive portfolio of small molecules and new biological entities at different stages of drug development (discovery, nonclinical and clinical development, initial registration, post-marketing/maintenance activities, peri/post Loss of Exclusivity). The Specialty Respiratory and Oncology portfolio offers a large variety of unique opportunities for driven individuals seeking to grow in their regulatory career due to the diversity of products/activities (e.g. New Mechanism of Action, Orphan Drug, Model-Informed Drug Development, Digital Health, Collaboration with Global Health Organization).

Essential Duties & Responsibilities:
 
Develop, coordinate and execute Global and US regulatory strategies in the Respiratory and Oncology therapeutic area for assigned projects with the support of the global regulatory team.  
Lead the preparation and submission of original and supplemental applications to regulatory agencies.  He/she will critically review submission documents in accordance with applicable requirements and with minimal supervision in order to prepare high quality regulatory submissions to the FDA.
Develop and communicates effective regulatory strategies for global product development, and recommends such strategies to RA management, team members and supervisors as appropriate which requires proactive identification and solutions to possible issues.
Lead Global Regulatory Teams including preparation of Global Regulatory strategy documents, routinely meeting with teams to ensure thorough communication.
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.
Oversee and ensure the preparation of INDs, NDAs, SNDAs, BLAs, ODs, and MAAs including liaising with U.S. and ex-US regulatory personnel as required.  Conduct gap analysis in a timely manner.  Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required.

Qualifications

Position Requirements:

Education required:  Bachelors Degree in scientific field

Education preferred:  PharmD, PhD, or Masters degree

Experience required:  Minimum of 7 years of experience in Regulatory affairs with at least 4 years in a Global/Regional Regulatory Strategy role.

Experience preferred:  Proven experience setting strategy in preclinical clinical or marketed products regulatory.  In-depth knowledge of FDA regulations regarding preclinical and clinical requirements.  Experience with IND, NDA, and/or BLA filings.  Experience with eCTD

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: 2019-08-28 Expires: 2019-10-19

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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Senior Manager Regulatory Affairs

Teva Pharmaceuticals
Frazer, PA 15084

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