3 days old

Manager Regulatory Affairs

Parsippany, New Jersey

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!

 

We offer 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. or more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

 

R&D:
Tevas 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.

 

The Manager, Regulatory Affairs US Gx Labeling will report to the Dir Regulatory Affairs, Gx RA Commercial - Labeling & Artwork - US and you will be responsible for reviewing and approving established labeling documents (Pre- and Post-approval products), created by direct reports as well as Mumbai colleagues, ensuring the preparation of high-quality US Rx and OTC Gx labeling documents, filed under an ANDA and/or 505(b)2, while adhering to federal regulations and meeting deadlines driven by company goals.


 
In your new role we are looking for strong  firm knowledge of labeling regulations and be considered a Subject Matter Expert (SME) as it relates to Structured Product Labeling (SPLs), drug listing, and patent/exclusivity carve outs.

 


Essential Duties & Responsibilities
 Responsible for assuring that projects are assigned to direct reports or external team members to meet departmental goals, FDA timelines, and to ensure the team adequately functions to meet all company objectives.
 Communicate, plan, prioritize, and perform training in order to ensure labeling documents are prepared to align with company goals and submission requirements for (Pre- and Post- approval) ANDAs / 505(b)2s and ensure labeling meets all legal and regulatory requirements.
 Perform in depth reviews of labeling and submission documents, for quality, content, and accuracy, prior to final disposition.
 Hands on leader in regard to daily work load; in addition to managerial responsibilities, this position could  have independent work assignments to manage on behalf of the team, if needed, as well as participate in the preparation of labeling submission documents.
 Establish/maintain a tracking database to capture all assigned pre-and post approval labeling projects.
 Review Structured Product Labeling for team projects to ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDAs Electronic Submission Gateway, upon application approval, for timely posting to DailyMed in order to meet launch readiness, eliminate detainment issues in Customs for products shipping into the US from foreign manufacturing sites, and maintain current labeling content on DailyMed website.
 Work with Regulatory Operations to ensure submissions are reviewed and transmitted to FDA on-time while following the eCTD requirements.
 Attend project meetings to ensure labeling timelines are met and provide labeling updates to the project team for those products being discussed.
 Provide guidance and leadership with regard to best practices in the labeling arena.
 Maintain a metric of all team projects for reporting purposes.
 Create, train, and/or revise SOPs, as appropriate.
 Develop PowerPoint presentations for training or informational purposes.
 Maintain knowledge of regulations, guidelines, and standard operating procedures applicable to Rx and OTC labeling.
 Participate in continuous improvement efforts related to business practices and tools utilized within the role.
 Performs all other job related duties as required by management.
 

Qualifications:


 BA/BS with a Scientific or Regulatory background or equivalent combination of education and experience
 5 plus years of pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on Gx labeling.
 Ability to lead a team and manage/prioritize projects
 Proficient in patent/exclusivity carve-outs
 Proficient in SPL development and drug listing requirements.
 Ability to multi-task in a fast paced work environment
 Have exemplary oral and written communication skills
 Have extensive knowledge of FDA regulations and guidances related to the creation of labeling for ANDAs and 505(b)2s.
 Have knowledge of FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions.


 
Specialized or Technical Knowledge, License, Certifications needed:


 PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
 Adobe Acrobat Professional is a must
 Text Verification Tool
 Extensive knowledge in the establishment of structured product labeling, data elements, as well as drug listing requirements/regulations
 

Categories

Posted: 2021-02-22 Expires: 2021-03-24

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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Manager Regulatory Affairs

Teva Pharmaceuticals
Parsippany, New Jersey

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