Abbvie, Inc Lake Bluff , IL 60044
Posted 3 weeks ago
Company Description
AbbVie'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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Associate Director, Regulatory Affairs, Strategic Global Labeling
Responsibilities:
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.
Significant Work Activities
Qualifications
Qualifications:
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.
Leveling of the role is determined by individuals qualifications.
Additional Information
Applicable only to applicants
Abbvie, Inc