Plans and prepares complex regulatory submission documents for US FDA regulatory filings, with minimal supervision. Utilizing detailed, in-depth understanding of FDA regulations for device products, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Submissions: Plans and prepares complex regulatory documents for global registrations under minimal supervision. Resolves submission problem areas with minimal input from supervisor. Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision. Review of labeling and packaging components to ensure accuracy and compliance with governmental regulations
Advisory Responsibilities: Participates on and/or leads global regulatory teams. Provides independent regulatory strategy and guidance to global product owner/project team. Works with 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
Communications: Maintains professional relationships with functional areas outside regulatory. Develops professional relationships with FDA reviewers through supervised process. Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others. Prepares documentation that is complete, accurate, and on time. Conveys information on team timelines and status to supervisor. Delivers presentations within the Company, as required, with input from supervisor..
Regulatory Compliance: 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. Supervisory Responsibilities: Performs peer review of complex regulatory documents. With minimal input from supervisor, identifies and recommends solutions for problems identified. Assists in aspects of training for personnel and may supervise, as appropriate.
Education and Experience Guidelines
Education equivalent to a BS degree in a scientific field, plus 4-6 years experience in medical device or regulatory affairs industry;; or
Education equivalent to a MS degree in a scientific field, plus 2-4 years experience in medical device or regulatory affairs industry; or
Education equivalent to a PhD degree in a scientific field, plus 0-2 years experience in regulatory affairs or medical device industry.
Essential Skills and Abilities
Experience with Class III implantable devices
Excellent communication skills, verbal and written.
Excellent interpersonal skills and supervisory potential.
Computer literate with excellent knowledge of Allergan systems for electronic storage and submission
In-depth knowledge of regulations
Good negotiation skills.
Allergan, Inc. - 2 years ago
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and...