Senior Manager, Regulatory Affairs

Apotex Inc.

Senior Manager coordinating regulatory affairs and co-development projects for a Canadian global health company. Overseeing submissions and product lifecycle management with a focus on compliance and teamwork.

Posted 5/5/2026full-timeMumbai • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Coordinate within team and third-party manufacturing/development sites for co-development projects
Author/Review of dossiers, deficiency responses and supplements/variations to various Regulatory Authorities
Responsible for coordinating internally and externally for New Product Launch of Co-development projects
Responsible for quality eCTD/CTD submissions to various Regulatory Authorities
Assess and provide regulatory strategy for changes proposed by different third-party manufacturers for co-development products
Collaborate as a team member to achieve outcomes
Ensure personal adherence with compliance programs and policies

Requirements

What you’ll need

M.Sc/B.Pharm/M.Pharm/Ph.D
Sound understanding regulatory affairs submissions
Expertise in product life cycle management
People management skills
Ability to learn and adapt quickly
Ability to manage full workload across multiple projects
Excellent verbal and written communication skills
8 to 10 years of experience in Regulatory Affairs activities, including 3 to 4 years in team/people management

Benefits

Comp & perks

Accommodation for applicants with disabilities as part of recruitment process

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory affairs submissionsproduct life cycle managementeCTD submissionsCTD submissions

Soft Skills

people managementadaptabilityproject managementverbal communicationwritten communicationteam collaboration

Certifications

M.ScB.PharmM.PharmPh.D