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Senior Manager, Regulatory Affairs - Facial Fillers

Company: Allergan
Location: Irvine
Posted on: October 11, 2019

Job Description:

Allerganplc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a newindustry model - Growth Pharma.?Allergan is focused on developing,manufacturing and commercializing branded pharmaceutical, device, biologic,surgical and regenerative medicine products for patients around the world.?Allerganmarkets a portfolio of leading brands and best-in-class products for thecentral nervous system, eye care, medical aesthetics and dermatology,gastroenterology, women's health, urology and anti-infective?therapeuticcategories. With commercial operations in approximately 100 countries, Allerganis committed to working with physicians, healthcare providers and patients todeliver innovative and meaningful treatments that help people around the worldlive longer, healthier lives every day.?Allergan is a companythat will inspire you to aim high with your ambition. Where you can buildbridges all over the world. Where you can power ideas that drive change. Andwhere you will act fast and drive results for customers and patients.?Power your future & join our bold team.?Position OverviewPlans and prepares complex Class III medicaldevice regulatory submission documents for the US. Provides support for globalregulatory filings, including EU, China, and Japan.? Utilizing detailed, in-depth understanding ofmedical device regulations, leads and participates in global regulatory teams,interprets regulations, and provides regulatory guidance.? Supports management with regulatory programsplanning and implementation of departmental strategies and policies.Main Areas ofResponsibilities Submissions, development and lifecycle maintenance Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision. Resolves submission problem areas with team. 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. Manages post-approval projects not requiring a global core team. Approves manufacturing process changes as appropriate.? Plans and 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. Advisory Responsibilities Participates in global teams and provides regulatory strategy and guidance to global product development teams. Under minimal supervision develops US regulatory filing strategy. Provides regulatory strategy and guidance to global teams. Makes recommendations to shape the global strategy in line with regional/commercial objectives Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness. 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.? Communications and Business Support:? Represents department on global project teams. Maintains professional relationships within the regulatory groups and with functional areas outside regulatory Develops professional relationships with Health Authorities when required. Has an awareness of key individuals within the FDA to ensure a clear understanding of requirements and effective representation of Allergan Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others.? Conveys information on team timelines and status to supervisor.? Delivers presentations within the Company, as required. Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.? Supervisory/Mentoring Responsibilities: Performs peer review of complex regulatory documents.? Provides leadership and development support to the Regulatory team. As appropriate, supervises and ensures training and development for Regulatory staff to ensure execution of all duties in a timely and efficient manner.Fostersa dynamic working environment by appropriately challenging processes, inspiringa shared vision, enabling others to act, leading by example, and encouragingintra- and inter-departmental team members to meet and/or exceed expectations.? Process and Organizational Effectiveness Provides input into development of processes to leverage Allergan 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 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 activitiesUpdatesand maintains appropriate SOPs for the departments.? Financial ManagementResponsible for ensuring budgets and forecasts are developedand actuals managed
*LI-ML Requirements Analytical thinking and problem-solving skills Excellent written and verbal communication skills. Good negotiation skills. Self-motivated with ability to work well independently and with others. Excellent organizational skills and attention to detail. Ability to handle multiple projects simultaneously and maintain flexibility. Experience with Adobe Acrobat, Excel, Power Point, and 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 US and EU regulations for Class III medical devices Demonstrated, in depth knowledge with IDE and PMA submissions Experience creating, reviewing, updating CERs Ability to guide and delegate and analyze training needs and conduct training. Ability to demonstrate leadership in job performance by example. Ability to function in a controlled environment regulated by FDA QSRs and to handle confidential data. Ability to lead and motivate others. Ability to meet deadlines; take initiative and make decisions within department/company guidelines.?Education Education equivalent to a BS degree in a scientific field, plus 8 years? experience in regulatory affairs; or Education equivalent to a MS degree in a scientific field, plus 6 years? experience in regulatory affairs; or Education equivalent to a PhD degree in a scientific field, plus 4 years? experience in regulatory affairs Class III medical device experience required.

Keywords: Allergan, Irvine , Senior Manager, Regulatory Affairs - Facial Fillers, Executive , Irvine, California

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