Regulatory Affairs Manager
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.
Plans and prepares complex regulatory submission documents for US or OUS regulatory filings. Utilizing detailed, in-depth understanding of regulations for device products, leads and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.
Duties and Responsiblities:
- Plans and prepares complex regulatory documents for US and potentially OUS submissions, under minimal supervision.
- Resolves submission problem areas with input from supervisor.
- Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision.
- Prepares complex expository and technical documents, logically constructed and comprehensive in content.
- Prepares documentation that is complete, accurate, and on time.
- Provides support for post-approval projects not requiring a global core team. Implements regulatory activities that support lifecycle management (e.g. PMA annual reports, post-approval changes, etc.)
- Reviews labeling and packaging components to ensure accuracy and compliance with government regulations. Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing.
- Participates on global regulatory teams.
- Works with team to resolve complex project issues.
- With supervision, develops US regulatory filing strategy. Provides regulatory strategy and guidance to global product owner/project team. Makes recommendations to shape the global strategy in line with regional/commercial objectives
- Works collaboratively with cross-functional team to resolve complex project issues.
- Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
- Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
- Ensures 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.
- Maintains professional relationships with functional areas outside regulatory.
- Develops professional relationships with Health Authorities through supervised process.
- Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others.
- Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.
- Performs peer review of complex regulatory documents.
- With input from supervisor, identifies and recommends solutions for problems identified.
- Assists in limited aspects of training for personnel and may supervise as appropriate.
- Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.
- Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness under limited supervision.
- Approves manufacturing process changes in consultation with supervisor, as appropriate.
- Interprets compliance regulations within the scope of departmental policy.
Education and Experience Guidelines
- Education equivalent to a BS degree in a scientific field, plus six years experience in regulatory affairs; or
- Education equivalent to a MS degree in a scientific field, plus four years experience in regulatory affairs; or
- Education equivalent to a PhD degree in a scientific field, plus two years experience in regulatory affairs.
Essential Skills and Abilities
- Analytical thinking and problem solving skills.
- Excellent written and verbal communication skills.
- Good negotiation skills.
- Ability to work well independently and with others.
- Excellent organizational skills and attention to detail.
- Ability to handle multiple projects simultaneously and maintain flexibility.
- Computer literate with excellent knowledge of AbbVie systems for electronic storage and submission. Experience with Adobe Acrobat, MS Excel, MS PowerPoint, and MS Word, and ability to learn new computer programs.
- Ability to understand and use technical documents, such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.
- Critical thinking skills and ability to follow-through.
- In-depth knowledge of US medical device regulations.
- Ability to function in a controlled environment regulated by FDA QSRs and to handle confidential data.
- Ability to meet deadlines; take initiative and make decisions within department/company guidelines.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.