Senior Manager Regulatory Affairs/Quality Assurance

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Description

• Manage site specific drug master file, site master file, annual product review reports and submission relevant documents as requested by clients and internal regulatory submission team
• Represents site and participates in meetings with global regulatory team and clients for clinical and commercial regulatory submissions relates strategic planning.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensures departmental training and compliance with established regulations, guidance’s and SOPs related to regulations for self and direct reports. Manages direct reports and assist in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups. Effectively delivers difficult messages to commercial organization while maintaining a positive and effective relationship
• Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions and exchange.
• Assesses R&D programs against region specific regulatory requirements
• Influences internal customers on Regulatory /Health Authority issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication
• Supervises the preparation and review of regulatory submissions consistent within a geographic region, Regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
• Serves as Health Authority liaison and interfaces with Health Authorities for meetings, teleconference, etc. Coordinate preparation of Health Authority meeting briefing packages
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.

Qualifications

Qualifications 

• Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related
• Preferred Education: Advanced Degree a plus. Certifications a plus
• Required Experience: 7 years Regulatory, R&D or industry related experience
• Proven skill at implementing successful global regulatory strategies
• Experience working in a complex and matrix environment
• Preferred Experience: 2-3 years’ experience in pharmaceutical regulatory activities
• Experience interfacing with government regulatory agencies

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.