Mgr Regulatory Affairs, Labeling

The opportunity

• The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA / 505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any / all team databases and trackers.
• The candidate must possess a firm knowledge of FDA US labeling regulations & guidances for products filed under an ANDA / 505(b)2 and should be a SME in all facets of US labeling, including, but not limited to SPL, PADERs, and AR compilation.
• Finally, candidate will be responsible for ensuring all required FDA reporting obligations are met in accordance with business objectives & regulations maintaining 100% compliance.

How you’ll spend your day

Your experience and qualifications

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