Senior Regulatory Strategy Lead — Health Products

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

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