Senior Manager, Regulatory Affairs

Innomar Strategies; Conshohocken (Montgomery County); Remote; CAD 119,000 - 187,000; Full time

Benefits offered by this job

Medical, dental, and vision care

Backup dependent care

Adoption assistance

Infertility coverage

Family building support

Behavioral health solutions

Paid parental leave

Paid caregiver leave

Job summary

Cencora, Inc. is hiring a Senior Manager, Regulatory Affairs with a clinical focus in Canada.

You will lead regulatory strategy and client engagements across the health product lifecycle, shape submissions for CTAs, INDs, NDAs, PLAs, and other regulatory documents, and partner with cross‑functional teams to deliver strategic guidance to clients and regulators. You will direct submissions, manage multiple engagements, and mentor teams while maintaining strong relationships with Regulatory

Qualifications

• 5–8 years of direct regulatory affairs experience across the health product lifecycle.
• Clinical research or regulatory consulting experience preferred.
• Strong knowledge of Canadian regulatory requirements and Health Canada processes.
• Experience with pre-market submissions and lifecycle submissions/post-market changes.
• Experience interacting with Regulatory Authorities (Health Canada, FDA, EMA) is an asset.
• French–English bilingualism preferred; RAC and leadership experience are assets.

Responsibilities

• Lead regulatory strategy and consulting engagements for life sciences clients.
• Direct planning, preparation, and review of regulatory submissions and documentation.
• Lead due diligence reviews and develop product labeling.
• Support product launch planning and promotional material review.
• Serve as principal client contact and interact with Regulatory Authorities.
• Lead or support agency meetings and provide strategic recommendations.
• Collaborate with cross-functional teams to align regulatory with development and business goals.
• Identify and mitigate regulatory risks and ensure timely, quality deliverables.
• Contribute to proposals, client development, and internal training.

Skills

Regulatory strategy

Client leadership

Cross-functional collaboration

Regulatory intelligence

Regulatory problem-solving

Education

Bachelor's degree in life-sciences

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

• 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 practice growth.
• French‑English bilingualism preferred, written and spoken.
• Regulatory Affairs Certification (RAC) and prior people‑leadership or consulting experience are assets.

What will help you succeed

You will thrive in this role if you are someone who: Enjoys translating complex regulatory requirements into practical paths forward. Balances scientific and regulatory rigour with client, patient and business needs. Is comfortable taking ownership of client relationships and senior‑level conversations. Brings calm, structure and sound judgement to ambiguous or time‑sensitive regulatory challenges. Is motivated by continuous learning and sharing expertise with colleagues and clients.

Why join Cencora?

You will join a purpose‑driven organisation working to create healthier futures. In this role, you will have the opportunity to: Influence regulatory strategy on a diverse range of client and product‑development challenges. Work with experienced regulatory, scientific and commercial colleagues in a collaborative environment. Build your consulting, leadership and business‑development capability alongside your regulatory expertise. Contribute to work that supports access to therapies and healthcare products.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

• medical, dental, and vision care
• backup dependent care
• adoption assistance
• infertility coverage
• family building support
• behavioral health solutions
• paid parental leave
• paid caregiver leave

Full time .

Salary Range* $119,100 CAD - 186,560 CAD

Affiliated Companies

Innomar Strategies Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose‑driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.