Associate, Regulatory Affairs

About the Company

Sun Pharma is a major global pharmaceutical organization focused on scientific innovation and a strong commitment to patients. The company develops high-quality medicines that are relied on by healthcare professionals and patients worldwide. Its portfolio includes innovative medicines, generic products, and consumer healthcare offerings that support better access to effective and affordable treatments across multiple therapeutic areas.

Its purpose is centered on improving health outcomes and positively impacting lives through accessible medicines.

Role Overview

The Associate, Regulatory Affairs will be responsible for preparing and submitting drug product filings to the US FDA and Health Canada, while also supporting international product registrations.

Key Responsibilities

• Draft and/or assess regulatory submissions for Health Canada and the FDA across dosage forms such as solid oral, liquid, topical semisolid, and injectable products, using eCTD format for documents such as DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, and provincial formulary packages.
• Build eCTD-compliant submissions, including the use of Adobe Acrobat for bookmarks and hyperlinks.
• Write responses to deficiency letters from regulatory authorities within required timelines.
• Prepare post-approval filings for the FDA and TPD, including CBE supplements, PAS, Notifiable Changes, and Supplements.
• Keep approved product monographs current in line with CRP-PM requirements.
• Maintain product compliance for FDA Annual Reports and TPD Annual Drug Notifications.
• Review and sign off on product labeling elements and promotional materials.
• Examine internal records such as master batch records, specifications, labels, and monographs to ensure alignment with regulatory standards.
• Support global drug product registration activities.
• Stay up to date on regulatory expectations from Health Canada, FDA, ICH, EMA, MHRA, TGA Australia, and related bodies.
• Carry out additional duties assigned by the manager.
• For customer-facing work, pass along any adverse event reported by customers to Pharmacovigilance/Drug Safety on the same day or within one business day.

Working Conditions

This position is based in an office, R&D, and manufacturing environment with heavy computer use. The schedule may vary depending on deadlines.

Compensation and Benefits

The expected base salary range for this role is CAD 66,000 to CAD 82,500 annually. Final pay may differ based on geography, experience, and other relevant factors. The role is also eligible for an annual performance bonus. Benefits include medical, dental, and vision coverage, life insurance, RRSP savings plan, employee assistance program, vacation time, and sick time.

Additional Terms

This posting is for an existing vacancy. The compensation and benefits described are governed by the applicable company policies, plans, agreements, and eligibility rules, and may be changed by the company when permitted, including changes tied to performance or market conditions. The job description is intended to describe the general scope of work and may be revised as business needs change. The employer offers equal employment opportunity and does not discriminate on protected grounds. Artificial intelligence is used in the screening, assessment, or selection process. The company does not accept unsolicited resumes from agencies or search firms for this role, and no fee will be paid for referrals submitted without a valid written and signed search agreement.