Manager, Labeling Regulatory Affairs Strategic Labeling
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
The Manager Labeling Regulatory Affairs Strategic Labeling develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. The Manager leads discussions to ensure global consistency of labeling and educates team members concerning global consistency of labeling.
Responsibilities:
- Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS) US Package Insert (USPI) Summary of Product Characteristics (SmPC) Structured Product Labeling (SPL) or Instructions for Use ( IFUs)
- Reviews and assesses data to determine whether accurate and reproducible. Works with clinical and safety teams to assure revised data is included as support documentation following approvals. Provides labeling input for Risk Management Plans Regulatory Strategic & Tactical Plans (RSTPs) and safety documents
- Drives strategic labeling processes within teams based on knowledge of success with other products. Makes recommendations to proactively optimize label language including effective use of Target Product Label (TPL) and Development Core Data Sheets (DCDS) as applicable for assigned products
- Maintains accurate files of labeling change history and associated documents including annotations to data sources
- Participates at team meetings reviews materials authors documents and meets timelines. Leads cross-functional teams to resolve labeling issues and address Ministry of Health (MOH) requests globally
- Works with safety groups on safety issues and leads discussion on safety related labeling changes. Makes decisions on own topics and those of direct reports based on experience with various products. Understands and supports regulatory implications of product profile.
- Works strategically with R&D Global Medical Affairs and safety to maintain accurate safety profiles for assigned products
- Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA
- Provides labeling support to Asset Development Team (ADTs) and affiliates including pre-approvals renewals and competitive analysis
- May indirectly manage work of other department members. Assists in training of new personnel and in the development of department processes/policies.
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: Bachelors 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
- Ability to supervise projects and set daily priorities. Able to work in a complex and matrix environment
- Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years experience in clinical or pharmaceutical preferred
- Cross-divisional team experience and working with cross-functional teams
- Strong problem solving with minimal guidance
- Note: Higher education may compensate for years of experience
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 the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and 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.
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 any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and 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
