Senior Manager, Regulatory Affairs

Value Apothecaries; Conshohocken (Montgomery County); On-site; CAD 120,000 - 180,000; Full time

Job summary

Cencora is seeking a Senior Manager, Regulatory Affairs with a clinical focus to provide strategic, client-facing regulatory consulting across the health product lifecycle. You will lead complex regulatory projects and interact with Regulatory Authorities (Health Canada and FDA) and cross-functional colleagues.

This role emphasizes translating evolving regulatory requirements into actionable guidance, developing product labeling, supporting launches, and managing multiple projects to meet

Qualifications

• Bachelor's degree in life sciences or regulatory field.
• 5-8 years in regulatory affairs across lifecycle.
• Experience with Health Canada and FDA is a plus.
• Clinical research or regulatory consulting background preferred.

Responsibilities

• Lead regulatory strategy and consulting engagements for life sciences clients.
• Prepare and maintain regulatory submissions across CTAs, INDs, NDAs, and PLAs.
• Interface with Regulatory Authorities and clients.
• Collaborate with cross-functional teams to align regulatory with development and commercial goals.
• Manage multiple projects within scope, timelines, and budgets.

Skills

Regulatory strategy

Client leadership

Project management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Make a meaningful regulatory impact At Cencora, we are united in our responsibility to create healthier futures. We support clients to navigate complex regulatory pathways for health products including prescription and non-prescription drugs (small molecule and biologics), medical devices, natural health products (NHPs), and cosmetics so that important therapies can reach the people who need them.

We are seeking an experienced Senior Manager, Regulatory Affairs with a clinical focus to provide strategic, client-facing regulatory consulting across the health product lifecycle. In this role, you will lead complex regulatory projects, shape practical regulatory strategies, and act as a trusted partner to clients, Regulatory Authorities (Health Canada and U.S. FDA) and cross-functional colleagues. This is an opportunity for a regulatory professional who combines technical knowledge with sound commercial judgement, confident client leadership and a practical approach to solving complex problems.

What you'll do

• Lead and manage regulatory strategy and consulting engagements for life sciences clients.
• Direct the planning, preparation, review and maintenance of regulatory submissions and associated documentation, including as applicable: Clinical Trial Applications (CTAs)
• Investigational New Drug applications (INDs)
• New Drug Submissions (NDSs)
• New Drug Applications (NDAs) and supplements
• Product Licence Applications (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 a principal point of contact for assigned clients and support productive interactions with Regulatory Authorities.
• Lead or support agency meetings, develop briefing materials and provide strategic recommendations on emerging regulatory issues.
• Partner with cross-functional teams to integrate regulatory strategy with development, quality, clinical, medical, commercial and business objectives.
• Interpret evolving regulatory requirements and translate regulatory intelligence into clear, actionable guidance for clients and internal stakeholders.
• Manage multiple projects to agreed scope, timelines, budgets and quality expectations.
• Identify and resolve regulatory risks, issues and competing priorities using sound judgement and a solutions-focused approach.
• Ensure deliverables meet applicable client requirements, standard operating procedures and quality expectations, while identifying opportunities for continuous improvement.
• Contribute to the growth of the practice by supporting proposals, presentations, new-business discussions and development of client relationships.
• Share expertise through internal training, mentoring, industry presentations, publications or webinars.
• Manages decision-making and conflict resolution surrounding regulatory issues for assigned projects and within their team
• Participate in professional activities such as offering industry training, conference presentations, publications and webinars as applicable
• Engage in continuous learning in order to provide effective consulting services and train/coach colleagues.
• Other duties as assigned

What you'll bring

Required qualifications and experience

• Bachelor's degree in a life-sciences discipline; an advanced degree in a relevant scientific or regulatory field is preferred.
• 5-8 years of direct regulatory affairs experience across the health product lifecycle
• Clinical research or regulatory consulting experience preferred
• Demonstrated experience developing pre-market submissions and managing product lifecycle submissions/post-market changes
• Strong working knowledge of Canadian regulatory requirements and Health Canada processes, with 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.
• Proven 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, with the ability to explain complex regulatory issues clearly to varied audiences.
• Demonstrated ability to build trusted relationships with clients and collaborate effectively in multidisciplinary teams.
• Strong business acumen and an interest in contributing to proposals, client development and p

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