Unilever Senior Regulatory Affairs Manager - Multiple Openings in Minneapolis, Minnesota
We have a few Senior Regulatory Affairs Manager. These roles can sit remotely in the Minneapolis MN area, Chicago IL area or Englewood Cliffs, New Jersey area.These roles are focused in either the OTC and Medical Devices or the Pharmacovigilance areas of expertise. Unilever is building an exciting new team to grow its presence in the Health and Wellbeing sector. Our goal is to help millions of people improve their health with solutions they can understand and trust. With a growing portfolio of purpose-led dietary supplement brands; Horlicks, Olly, Equilibra, Pukka Herbs and Liquid I.V. and plans to add more, we’re looking to add Senior Global Regulatory Affairs Managers to our global Health & Wellness regulatory team. Who You Are and What You'll DoOTC and Medical DevicesLead US OTC and Medical device regulatory function and partner with business to drive growth ambition. Manage and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.Participate in external policy and advocacy to create, grow and protect the business. Represent company on appropriate forums. Develop and execute robust end to end regulatory strategy to support innovation and compliance. Partner with other functions like quality, supply chain to ensure timely regulatory deliveries. Work with external companies to ensure appropriate regulatory framework is in place to ensure end to end regulatory compliance (e.g. CGMP, labeling, advertisement, sales & distribution, claim etc.) for the businessWork with in-house and external legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protectionManage the pre-market registration or notification process to enable product sale.Provide regulatory guidance, risk assessment, and management throughout the product lifecycle: New Product Development and Commercial projectsEnsures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products.Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the innovation/ product maintenance. Participate as an effective member of cross-functional product teams.PharmacovigilanceLead pharmacovigilance (PV) strategy and operations for Dietary supplement, OTC and Medical device business in US and other countries. Ensure regulatory compliance of safety reporting and other PV obligation Ensure appropriate PV systems and processes are in place to ensure regulatory compliance. Support safety evaluations, including strategy discussions, collaborating with R&D and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.Ensure all relevant staff are trained appropriately and ensure required training compliance. Oversee and supervise PV global outsourcing activities through identification, selection, negotiation, management, and maintenance of Good Pharmacovigilance Practices (GPVP) and required PV activities in assigned projects.Support Individual Case Safety Reports (ICSR) review, MedDRA coding, Sponsor’s positioning, case follow up, benefit-risk assessment for both marketed and investigational products.Work collaboratively with outsourced vendor on the execution of periodic aggregate safety reports (PADERs, PBRER, DSURS, etc.).Manage compliance with all regulatory requirements for periodic aggregate safety report deliverables. Partner cross-functionally internally to define reporting and submission requirements to enable vendor resource planning to deliver all safety reports.Support revisions within the Company Core Data Sheet (CCDS), and US Full Prescribing Information as needed.Manage Safety Data Exchange Agreement (SDEA) and Pharmacovigilance Agreements (PVA) development and updates for Market Authorization Holders (MAH), as needed, to comply with regulations. Confirm compliance with all SDEAs and PVAs.Escalate issues with proposed mitigation strategies.Support triage, review, processing and evaluation of Individual Literature Case.Support internal and external audit activities and maintain audit and inspection readiness. Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes.Serve as the primary functional interface from Pharmacovigilance for subject matter expertise on aggregate safety reporting content.Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the innovation/ product maintenance. What You'll Need to SucceedBachelors Degree required. Master’s Degree in regulatory affairs, science, medical sciences, pharmacology etc. a huge plus10+ years of OTC, Medical Device and Consumer Healthcare regulatory experience or PV experience in pharma industry, OTC/ Medical Device/ Health Supplement industry experience required.Knowledge and experience on FDA and Health Canada regulatory and applicable laws and regulations, as well as of cGMP standardsExtensive knowledge and understanding of global PV practices and understanding of US, Canada and ICH PV regulatory requirements Proven regulatory advocacy skills with measurable deliverables in OTC/ Medical Device space in US. Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skillsAbility to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as, internal and external stakeholdersAbility to work well autonomously and within a team in a fast-paced and deadline-oriented environment.Excellent English written and verbal communication skills. ------------------------------------Unilever is an organization committed to diversity and inclusion to drive our business results and create a better future every day for our diverse employees, global consumers, partners, and communities. We believe a diverse workforce allows us to match our growth ambitions and drive inclusion across the business. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information, please see Equal Employment Opportunity PostersEqual Opportunity/Affirmative Action Employer Minorities/Females/Protected Veterans/Persons with DisabilitiesEmployment is subject to verification of pre-screening tests, which may include drug screening, background check, credit check and DMV check. If you are an individual with a disability in need of assistance at any time during our recruitment process, please contact us at NA.Accommodations@unilever.com. Please note: This email is reserved for individuals with disabilities in need of assistance and is not a means of inquiry about positions or application statuses.
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