- Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team (e.g., 510(k) premarket notifications, Premarket Approval (PMA) applications, Investigational Device Exemption (IDE) applications, Medical Devices Regulations (MDR), Notified Body requirements, CE Mark, In-country notifications, etc.).
- Work cross functionally with teams to support combination product and device submissions and seek clarification on regulatory requirements; provide regulatory guidance and support to internal stakeholders, including Label Sub teams, R&D, Quality Assurance, Human Factors, Operations S&T, Manufacturing, Ad Promo and others as needed.
- Review and interpret regulations and standards related to combination products and devices to ensure compliance with applicable laws and regulations related to safety and effectiveness.
- Drive strategic labeling processes within teams based on knowledge of product class; provide and recommend optimal labeling language based on evaluation and knowledge of project data.
- Present proposed labeling at Senior level meetings including Executive Labeling Committee and others as required for product milestones and Health Authority interactions, ensuring that Labeling Sub team-endorsed strategies are efficiently implemented, endorsed by Senior Leadership, and aligned with changing regulatory and business needs.
- Participate in the development and implementation of regulatory strategies for new product development, stay current with Global industry trends and best practices in combination product and device regulatory affairs, review and comment on changing regulation and guidance.
- Provide training and development opportunities to direct reports, manage, and oversee Strategist work to ensure alignment with company goals and expectations.
- Required education: BS or BA degree in a technical area (biology, chemistry, pharmacology, engineering, microbiology, medical technology).
- Preferred education: Advanced degree preferred, professional certification(s) a plus.
- Required experience: 5 - 8 years medical device, pharmaceutical, regulatory, or industry-related experience.
- Preferred experience: 5+ years with combination product and medical device labeling
- Experience working in a complex and matrix environment, possessing strong oral and written communication skills.
- Understanding of regulatory concepts, knowledge of medical and regulatory terminology, guidelines, standards, etc.
- Experience developing and implementing successful global regulatory labeling strategies.
- Experience with InDesign a plus.
- 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.
- This job is eligible to participate in our long-term incentive programs.
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Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Lake Bluff, United States - AbbVie
Description
Job Description
Job DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionThe Associate Director, Regulatory Affairs, Strategic Global Labeling – Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation. This individual has influence within the department and is recognized as an expert resource on combination product and device labeling topics. They ensure that combination product and device labeling data are identified, evaluated and effectively presented for registration worldwide. The individual represents the organization at Senior level meetings regarding combination product and device labeling, including Target Product Label (TPL), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (SmPC), Instructions for Use (IFU), and other documentation for healthcare providers and end user. Under the Director of Strategic Labeling, they establish combination product and device labeling procedures and policy compliant with changing regulatory environments; manages, develops, and supervises labeling Strategists.
Responsibilities:
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
QualificationsQualifications:
***Leveling of the role is determined by individuals qualifications.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
