Senior Regulatory Affairs Specialist

1 week ago

North York ON MH T, Canada AAPS Pharma Full time

Job Title:

Senior Regulatory Affairs Specialist

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 Senior Regulatory Affairs Specialist to support our compliance and product development initiatives.

Key Responsibilities:

  • Prepare, submit, and manage 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
  • Monitor changes in regulations and assess impact on business
  • Act as liaison with health authorities and regulatory agencies
  • Lead audits and respond to deficiency letters or health authority inquiries
  • Support client projects and business development initiatives
  • Collaborate with cross-functional teams to strengthen client relationships and ensure timely, high-quality deliverables
  • Support the business development team by providing regulatory expertise during client meetings, proposals, and capability presentations.
  • Assist in identification of potential leads based on regulatory needs, market gaps, and industry trends.
  • Participate in strategic outreach efforts to pharmaceutical, biotech, and medical device companies.
  • Contribute to marketing initiatives such as regulatory insights, whitepapers, or webinar content.

Qualifications:

  • B.Sc. or higher in Life Sciences, Pharmacy, or related field
  • 10+ years of experience in regulatory affairs (pharmaceutical or biotech)
  • Strong knowledge of FDA, Health Canada and international regulatory pathways is a must
  • Excellent communication, writing, and organizational skills
  • Regulatory Affairs Certification (RAC) is an asset
  • MBA or equivalent business acumen is an asset

How to Apply:

Please submit your resume with "Senior Regulatory Affairs Specialist" in the subject line.

Job Type: Full-time

Pay: Up to $110,000.00 per year

Work Location: In person

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