Manager, Regulatory Affairs, Strategic Global Labeling (Office-based)
Share
Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products ensuring compliance with company procedures and applicable regulations.
Responsibilities:
- Develop and maintain target labeling and prescribing information including company core data sheets and US and EU labeling documents through the product lifecycle. Make recommendations to proactively optimize labeling language including effective use of target labeling as applicable for assigned products. Product portfolio will include pharma OTC and/or device or combination products.
- Lead cross-functional labeling teams to develop comprehensive label strategies and create accurate labeling for development and marketed products by understanding supporting data and leveraging knowledge of labeling regulations precedent and company processes to guide strategy and content development.
- Lead cross-functional team discussion of safety-related labeling changes and process the labeling in accordance with internal labeling procedures.
- Maintain documentation within regulatory information management system.
- Co-lead cross-functional labeling and regulatory strategy team (with guidance).
- Provide guidance to affiliates on labeling proposals and responses to health authorities.
- Present/communicate labeling strategies and decisions to senior and executive leadership.
- Represent the department on cross-functional regulatory and safety teams; contribute to and review regulatory and safety documents for labeling content.
- Contribute to or lead departmental or cross-functional process improvement initiatives.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications :
- Required Education: Bachelors degree in Pharmacy Biology Chemistry Pharmacology or related subject. Preferred Education: Advanced degree. Certifications a plus
- Required Experience: 6 years in Pharmaceutical regulatory R&D or industry related area. Experience in labeling or area that could link to labeling. Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years experience in clinical or pharmaceutical preferred
- Strong communication collaboration time management and problem-solving skills.
- Proactive able to manage multiple projects simultaneously and set daily priorities. Able to work in a complex and matrixed environment.
- Ability to lead live or virtual meetings and document team decisions.
- Note: Higher education may compensate for years of experience
- This role will work a hybrid work schedule (3 days in office) from the Irvine California headquarters.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
