Senior Manager, Regulatory Affairs

🔥 5 minutes ago

🇨🇦 Canada – Remote

💵 $119.1k - $186.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Lead and manage regulatory strategy and consulting engagements for life sciences clients • Plan, prepare, review and maintain regulatory submissions and associated documentation, including CTAs, INDs, NDSs, NDAs and supplements, PLAs, DIN submissions, regulatory responses, amendments and post-approval activities • Lead due diligence reviews • Develop product labeling • Support product launch planning and advertising/promotional material review • Serve as principal point of contact for assigned clients and support interactions with Regulatory Authorities • Lead or support agency meetings, develop briefing materials and provide strategic recommendations on emerging regulatory issues • Partner with cross-functional development, quality, clinical, medical, commercial and business teams • Interpret evolving regulatory requirements and translate regulatory intelligence into actionable guidance • Manage multiple projects against scope, timelines, budgets and quality expectations • Identify and resolve regulatory risks, issues and competing priorities • Ensure deliverables meet client requirements, standard operating procedures and quality expectations • Support proposals, presentations, new-business discussions and client relationship development • Share expertise through training, mentoring, industry presentations, publications and webinars • Manage decision-making and conflict resolution for assigned projects and within the team • Engage in continuous learning and train or coach colleagues • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in a life-sciences discipline required • 5–8 years of direct regulatory affairs experience across the health product lifecycle • Experience developing pre-market submissions and managing product lifecycle submissions/post-market changes • Strong working knowledge of Canadian regulatory requirements and Health Canada processes • Familiarity with relevant ICH requirements • Experience with FDA, EMA and other international regulatory environments is an asset • Experience managing or supporting interactions with Regulatory Authorities • Ability to lead several concurrent client projects while managing timelines, scope, quality and budget considerations • Strong strategic thinking, analytical judgement and problem-solving capability • Excellent written, verbal and presentation skills • Ability to explain complex regulatory issues clearly to varied audiences • Ability to build trusted relationships with clients and collaborate effectively in multidisciplinary teams • Strong business acumen and interest in proposals, client development and practice growth • French-English bilingualism preferred, written and spoken • Regulatory Affairs Certification (RAC) and prior people-leadership or consulting experience are assets

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities

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