Sr Mgr, Regulatory Intelligence
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.
The Regulatory Intelligence manager will be responsible supporting AbbVie Global Regulatory Intelligence Program including compendial, pharmaceutical, medical device, biologics, OTC, and cosmetic regulatory surveillance. The manager is responsible for performing impact assessment and monitoring regulatory changes and emerging regulations. Additionally, the manager may lead implementation of less complex regulatory changes and support global projects to ensure timeliness and commitment are in alignment with the project plan and guidelines. The manager will support the timely communication of the implementation plan to stakeholders. The manager will be responsible for providing intelligence information and support throughout the Quality and Compliance organization. Update corporate documents such as policies, standards, SOPs, and work instructions as required by global regulatory requirements.
The employee must conduct their work activities in compliance with all AbbVie internal requirements and all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Primary Job Responsibilities:
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Independently performs impact assessment on regulatory changes
- Support the development, maintenance, and continuous improvement of the regulatory intelligence program (includes compendial, pharmaceutical, medical device, biologics, OTC, and cosmetic surveillance) to ensure process gaps are addressed.
- Support the establishment of milestones and metrics to monitor the performance of the regulatory intelligence (includes compendial, pharmaceutical, medical device, biologics, OTC, and cosmetic surveillance) program
- Develop and provide training on the process and requirements for the Regulatory Intelligence/Compendia process to all stakeholders
- Support the timely communication of regulatory changes
- Support/manage team activities related to project plan and databases and help drive conflict resolution across functional team
- Support updates to corporate policies and standards as appropriate in compliance with global regulatory requirements and changes.
- Collaborate with business partners and vendors to develop lasting relationships that help strengthen and assure communication between parties while assuring highest quality of service
- Ability to travel (10-20%)
- Proficient in computer skills and hands on experience in different computer software such as database management, spreadsheets, project management, presentations, word processing flowcharting and/or any other similar type of program.
Education and Experience:
- 4-year college degree, with an emphasis in a technical discipline such as Chemistry, Microbiology, Pharmaceutics, or Biochemistry, Engineering. Additional scientific training M.S., Ph.D, and/or MBA a plus.
- Minimum of 3 years of combined industry and QA/QC experience in pharmaceutical, biologics, and/or device environment.
Knowledge and Skills:
- Good judgment and decision-making capability in the technical and compliance areas
- Efficiency in planning, coordinating and managing multiple projects
- Ability to work in multi-disciplinary teams and coordinating the activities with others
- Good analytical, interpersonal, and verbal/written communication skills, with internal constituencies
- Integrity, judgment, and the ability to hold one’s ground under pressure
- Ability to work in a multinational, multicultural and highly matrix environment
- Team player with strong customer orientation
- Must be detail and quality oriented
- Effective problem-solving skills
Significant Work Activities
Yes, 20 % of the Time
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.