Manager, Regulatory Affairs

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 .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You to Know

In this new and exciting position, the Manager, Regulatory Affairs primarily serves a supportive role to the Global Regulatory Lead for development-stage pharmaceutical products. The Manager serves as the Regulatory Lead for mature products while managing, reviewing, planning and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Manager will interpret regulations, and provide regulatory guidance to global regulatory teams. He/She has the authority to submit complex submissions and may act as primary AbbVie contact with US FDA and may lead selected US FDA meetings while ensuring technical accuracy and regulatory compliance of submissions. He /She may train and provide guidance to lower level staff.

In Regulatory Lead or supportive role, the Manager drives global regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives as well as provides regulatory affairs perspective to project teams and other functions.

Lastly, the Manager supports management with development and implementation of departmental strategies and policies.

YOU ARE more than just a title, YOU ARE...

• A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
• First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

• Provide appropriate Regulatory input to project teams via Global Regulatory Teams.
• Ensure planned drug development activities comply with health authority guidelines, and in cases where they do not, provide a critical analysis of the associated risks and issues.
• Make recommendations to GRL and/or drug development teams in order to shape the global strategy in line with regional/commercial objectives.
• Establish relationships with colleagues as well as global regulatory team thereby ensuring local RA activities are in line with global and regional business priorities.
• Support the drug development strategy, defining options for Scientific Advice, creating briefing packages and coordinating and leading US health authority meetings.
• Be responsible for US specific submissions (strategy and package preparation)
• Manage the preparation of clinical trials and submissions and routine CT maintenance.
• Support the communication of regulatory strategy in support of new product registration, in line with commercial objectives.
• Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.
• Ensure input from Advertising and Promotional Compliance team, as appropriate.
• Develop an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of AbbVie.
• Act as primary contact with US FDA as required.
• Plan and implement regulatory activities in support of lifecycle management (e.g Annual reports, label and CMC changes).
• Submit product labeling in compliance with legal/regulatory requirements and communicate planned/approved changes with APC, medical affairs and marketing.
• Ensure effective implementation of filing plan and publishing of documents.
• Ensure effective planning, oversight and management of submissions including Virtual Document preparation and RAPID entries.
• Ensure archiving of activities, especially submissions, internal memos and key correspondence.
• Provide status updated to management.
• Be responsible for communication of submission and approvals to relevant cross functional teams.
• Provide project teams with clear, constructive regulatory advice and intelligence to help maximize business opportunities.
• Define regulatory requirements, develop and subsequently implement plans in support of global/regional/country business initiatives.
• Provide input into development of processes to leverage AbbVie global processes and infrastructure and maximize efficiency and effectiveness.
• Provide input into critical metrics and management reports.
• Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.
• Maintain a performance and improvement culture.
• Ensure roles and responsibilities for external services within a project are clearly defined and documented.
• Proactively resolve issues related to outsourced activities.
• Follow all approved AbbVie procedures and guidance.
• Ensure that budgets and forecasts are developed, and actuals managed in line with regional requirements.

#LI-PD1

Qualifications

You Bring

• Bachelors degree required. Advanced degree preferred.
• 3 -5 years' regulatory affairs experience .

In this role, we're looking for a leader who will :

• Act as an Owner
• Be Excellence Focused
• Act as an Influencer

Job Type
Standard

Schedule
Full-time

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.