Allergan Regulatory Affairs Manager (m/f/d) - Alpine in United States
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 at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
You are the source of local regulatory expertise in the registration and post-licensing support of medicinal products and medical devices for Switzerland and Austria and you develop and maintain excellent knowledge of national regulatory procedures and requirements.
In conjunction with the Senior Manager Regulatory Affairs, you plan and implement regulatory activities in support of new product approvals, marketed product licences and lifecycle management initiatives, in line with regulatory requirements and local business needs. You ensure compliance of product labelling and provide support to Pharmacovigilance and Medical Information activities.
In accordance with Art. 17 and 18 of the Swiss ordinance on establishment licences (AMBV) you support the Quality Assurance department to ensure that the medicinal products are imported and distributed in Switzerland in accordance with the rules of good distribution practice (GDP) and Swiss legislation and that these products are handled appropriately.
In conjunction with the Senior Manager Regulatory Affairs, you build and maintain relationships with the Swissmedic and AGES, local experts/consultants and trade associations, as appropriate.
Regulatory Affairs (Switzerland and Austria)
Develops and maintains excellentknowledge of local regulatory procedures and requirements. Provides clear,timely and constructive regulatory advice and intelligence on local regulatoryrequirements to the Global Product Owner (GPO) and European Regulatory Affairsgroup (EU RA), as required.
Plans and implements regulatoryactivities in support of new product approvals, maintenance of marketed productlicences and lifecycle management initiatives.
Ensures planning & tracking ofactivities in the Regulatory Affairs Product Information Database (RAPID),publishing of submissions and archiving of critical documents in accordancewith regional and local processes.
In conjunction with the SeniorManager Regulatory Affairs, builds and maintains relationships with Swissmedic,AGES and other Agencies, as appropriate. Supports any Agency contacts, asrequired, including Scientific Advice and other Agency meetings.
Packaging Material Compliance
Reviews and approves all product-relatedpackaging and labelling components (e.g. outer packaging, patient informationleaflets, SPCs) for Switzerland and Austria. Liaises with EU RA and LabellingImplementation and New Product Co-ordination group (LINC) to ensure that anylabelling changes are planned and implemented in line with company and agencyexpectations in due time.
Reviews and approves EngineeringChange Requests.
Supports EAMQA and WWQA inaddressing product non-conformances that impact Switzerland, in line withregional and local processes.
Performs artwork and labelcompliance reviews, as requested.
Reviews and approvesGerman/French/Italian translations of packaging material for ophthalmologicalMedical Devices.
Reviews German/French/Italiantranslations of packaging material incl. DFUs for other Medical Devices uponrequest (e.g. for dermal fillers, etc.).
Acts as local contact Person by providingRegulatory information (e.g. new product introduction, update of productinformation, approved PSURs, RMPs and RMP materials, updated tracking lists) forthe contractor for Pharmacovigilance for Switzerland and Austria (LSO).
Supports the Senior ManagerRegulatory Affairs in informing involved Allergan staff of any safety relevantchanges in Swiss and Austrian labels.
Processes and Compliance
Follows all relevant global, regional,and local policies and processes.
Ensures that local processes arereviewed and updated regularly and are aligned with global/regional processesand local requirements.
Maintains inspection readiness andcompletes post-inspection CAPAs in time.
Completes all requiredcompliance and ethics related trainings as well as trainings on applicableinternal policies and SOPs within required timelines.
Pharmacist or Life SciencesGraduate, ideally with post-graduate qualification in a relevant area orrelevant experience in the field of Regulatory Affairs and Quality Assurance
Excellent knowledge of Swiss (andAustrian) local pharmaceutical regulations and guidelines, knowledge of theEuropean regulations
1 to 2 years of Regulatory Affairsexperience, including a successful track record in the registration andmaintenance of pharmaceutical products
Experience in dealing with Swissmedic
Medical devices experiencedesirable
Experience in cross-functionalproject teams an advantage
Conversant with the primaryfunctions of pharmaceutical development, microbiology, toxicology, clinicalresearch and quality assurance
Excellent planning, organisational,and time management skills
German language skills on nativelevel, fluent written and verbal English language skills, good written French language skills,Italian language skills desirable
Ability to work effectively andcollaboratively intern and extern, across functions and geographies
Ability to cope with high workloadand pressure
Ability to prioritise workload appropriatelyto accomplish goals and objectives
Operates with high standards andattention to detail
Solution-orientedand performance-minded working method
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.