Senior Manager, Regulatory Affairs
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
The Sr. Manager serves as Regulatory Lead for development-stage and mature pharmaceutical products. He /She will manage, review, plan and prepare complex regulatory submission documents for global regulatory filings. Also, the Sr. manager will interpret regulations, and provide regulatory guidance to global regulatory teams. Has authority to submit complex submissions, act as primary AbbVie contact with US FDA, and lead US FDA meetings. Ensures technical accuracy and regulatory compliance of submissions. May train and provide guidance to lower level staff.
As a Regulatory Lead or supportive role, the Sr. Manager will drive global regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives. Additionally, He/She will provide regulatory affairs perspective to project teams and other functions. Will support management with development and implementation of departmental strategies and policies. Primary product responsibility is in the Neuroscience Therapeutic Areas. May have responsibility to work in one or more therapeutic areas, covering multiple projects as needed.
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.
- Be responsible for providing regulatory input into project teams, Global Regulatory Plans, and Global Regulatory Teams.
- Be responsible for ensuring planned drug development activities comply with health authority guidelines and in cases where they do not, provides a critical analysis of associated risks and issues.
- Make recommendations to Regulatory Management and drug development teams in order to shape the global strategy in line with commercial objectives.
- Ensure Alignment with cross functional teams.
- Establish relationships with US 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 trial-supporting submissions.
- Define global submission strategies, identifying risks and issues.
- Be responsible for 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 development, lifecycle management and/or maintenance.
- 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 the primary contact with Regulatory Agencies.
- 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 communicates planned/approved changes to relevant functions.
- Ensure effective implementation of filing plans and publishing of documents for own projects and, if applicable, direct reports.
- Ensure effective planning, oversight and management of submissions including VDoc preparation and RAPID entries of assigned projects and for those of, if applicable, direct reports.
- Ensure archiving of activities, especially submissions, internal memos and key correspondence.
- Provide routine status updates to management.
- Be responsible for the Notification of Regulatory activities and related database entry/data accuracy.
- Be responsible for accurate and timely communication of submission and approvals to relevant cross functional teams for own projects and, if applicable, direct reports
- Provide project teams with clear constructive regulatory advice and intelligence to maximize business opportunities.
- Define regulatory requirements, develops and subsequently implements, plans in support of global/regional/country business initiatives.
- Provide input into development of processes to leverage global processes and infrastructure and maximize efficiency and effectiveness.
- Provide input into critical metrics and management reports.
- Maintains 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.
- Update and maintain appropriate standard operating procedures for the department.
- Prepare and deliver presentations as required
- BS degree in a scientific field, plus six to eight years’ experience in regulatory affairs; OR
- MS degree in a scientific field, plus four to six years’ experience in regulatory affairs; OR
- PhD degree in a scientific field, plus two to four years’ experience in regulatory affairs.
In this role, we’re looking for a leader who will:
- Act as an Owner
- Be Excellence Focused
- Act as an Influencer
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Job Level Code
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.