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Sr Mgr Regulatory Affairs - 7198

Date: Jun 24, 2022

Location: West Chester, Pennsylvania, US, 19380

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!

Teva offers a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. If you would like more information please visit us at www.tevapharm.com or www.tevausa.com


Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
 

Job Description

The Senior Manager, Regulatory Affairs Brand Management (advertising and promotion) will be responsible for conducting regulatory assessment and research on regulatory precedence, in order to evaluate advertising/promotional regulatory issues for assigned Teva products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as the lead regulatory affairs representative on the Promotion and Advertising Review Committees (PARC) and Medical, Legal, and Regulatory (MLR) committees for assigned brands.

ESSENTIAL FUNCTIONS:

Responsibilities:
•    For assigned Teva brands, provide regulatory leadership and guidance to the marketing team and legal and medical information team members of the Promotion and Advertising Review Committee (PARC) in the development, review and approval of promotional labeling and advertising materials as well as sales training and other materials as required.
•    Work collaboratively with Regulatory Operations at all stages of development of materials reviewed by PARC, up to and including OPDP submissions.
•    Review/approve scientific materials (e.g., Medical Science Liaison presentations) and other materials (e.g., press releases) that are the responsibility of the medical, legal, and regulatory (MLR) committee.
•    For assigned Teva brands, serve as the FDA liaison for matters related to advertising and promotion.
•    Review regulatory guidelines and publications to keep apprised of new regulatory developments.
 

Qualifications


MINIMUM REQUIREMENTS:
Education: 

Experience

 
•    Bachelor's of Science from an accredited college or university 

•    Ten years of experience in the pharmaceutical industry or equivalent. 
•    At least one year of experience preferred involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry, including experience providing regulatory input and evaluation as part of a promotional review committee.
 
Knowledge/Skills/Qualifications/Competencies:
•    Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
•    Ability to determine essential components of regulatory requirements in order to include them in applicable policies and procedures.
•    Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
•    Proven ability to prioritize and meet project deadlines.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

: Associate Director, Promotional Review & Labeling 

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment


We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 
Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations. 


Nearest Major Market: Philadelphia