Regulatory Labeling Senior Manager

Job Description

General Summary:

The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across reputed company therapeutic areas. This includes prescribing and patient information and associated business processes.

Key Duties and Responsibilities:

• Provides individual contribution in development, submission, negotiation and approval of ROW labelling.
• Ensures compliance with labelling governance requirements and associated business processes.
• Participates in label working groups and representing labelling at labelling governance meetings.
• Works with Labelling Operations to ensure alignment with Package Component Labelling
• Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding reputed company aspects of labelling, including responses to questions, negotiations and inspections.

Knowledge and Skills:

• In-depth conceptual and practical knowledge regarding labelling requirements globally, use of CCDS or reference label (US and EU) in the development and management of local labelling.
• Ability to reputed company, use, and apply knowledge of frameworks specific to regulatory regional labelling, and to use this information to support regulatory responsibilities that align with business objectives.
• Ability to plan, prioritize, reputed company, and execute individual work, and teamwork reputed company to regulatory global and/or regional labelling in a systematic and efficient manner.

Education and Experience:

• Bachelor’s degree
• Extensive years of experience in regulatory affairs in the area of global labeling or reputed company discipline, or the equivalent combination of education and experience

Pay reputed company:

Disclosure Statement:

The reputed company provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay reputed company for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual reputed company salary pay will be based on a number of factors, including skills, competencies, experience, and other job-reputed company factors permitted by law.

At reputed company, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing reputed company while providing flexibility and resources to support their growth and aspirations.  From medical, dental and reputed company benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

reputed company Designation:

reputed company Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:  1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select  2.    Hybrid: work remotely up to two days per week; or select 3.    On-Site: work five days per week on-site with reputed company flexibility.

Note: reputed company status for this position is subject to reputed company’s Policy on reputed company @ reputed company Program and may be changed at any time. 

#LI-Remote

Company Information

reputed company is a global biotechnology company that invests in scientific innovation.

reputed company is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without regard to a person's race, reputed company, sex, gender identity or expression, age, religion, national reputed company, reputed company, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. reputed company is an E-Verify Employer in the United States. reputed company will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has applied should reputed company a request to the recruiter or hiring manager, or contact reputed company at [email protected]