Regulatory Affairs Associate

2 weeks ago

Toronto, Canada AAPS Pharma Full time

**Company Overview**

At AAPS Pharma, we embody our vision of being the foremost ally for pharmaceutical companies, distinguished by our steadfast dedication to quality, compliance, and timely delivery of services.

Led by a seasoned team with years of experience in the pharmaceutical industry, AAPS Pharma is committed to surpassing expectations by providing unparalleled expertise and support. We believe in fostering strong partnerships with our clients, listening attentively to their needs, and delivering tailored solutions promptly and efficiently.

As a rapidly growing team, we are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our compliance and product development initiatives.

**Key Responsibilities**:

- Assist in preparing and submitting regulatory submissions (e.g., NDS, SNDS, ANDS, NDA, ANDA)
- Ensure compliance with Health Canada, FDA, EMA, and other regulatory bodies
- Maintain regulatory documentation and track approval timelines
- Provide regulatory input throughout product development lifecycle
- Assist in audits and responses to deficiency letters or health authority inquiries

**Qualifications**:

- B.Sc. or higher in Life Sciences, Pharmacy, or related field
- 2 years of experience in regulatory affairs (pharmaceutical, biotech or medical device)
- Working knowledge of FDA, Health Canada and international regulatory pathways is a must
- Excellent communication, writing, and organizational skills

**How to Apply**:
**Job Types**: Full-time, Part-time, Fixed term contract

Work Location: In person

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