20th January, 2025
Senior Regulatory Affairs Associate - New Product Development
Type: 12-Month Contract
Work style: Hybrid (Mon/Tues/Wed in-office; Thurs/Fri remote)
Salary: $85K-$90K
Are you ready to take your regulatory affairs career to the next level? We’re seeking a passionate and experienced Senior Regulatory Affairs Associate to join our innovative and forward-thinking team. This is your chance to contribute to life-changing healthcare solutions and make a real impact in a dynamic industry.
What makes this role exciting?
- Flexible Hybrid Schedule: Enjoy a balance of in-office collaboration and work-from-home flexibility.
- Leadership Opportunity: Take charge of key regulatory submissions and play a critical role in ensuring compliance for new and innovative healthcare products.
- Mentorship and Growth: Share your expertise by guiding junior team members while expanding your own professional horizons.
- Be at the Forefront: Contribute to the development of groundbreaking products that improve lives.
Key responsibilities As a Senior Regulatory Affairs Associate in New Product Development (NPD), you will:
- Lead the preparation and submission of regulatory applications, including New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), Drug Identification Numbers (DIN), and more.
- Manage regulatory activities post-approval, including supplements, annual notifications, and compliance assessments.
- Collaborate across departments to maintain regulatory excellence and ensure adherence to industry standards.
- Provide training and mentorship to junior staff members, fostering a culture of learning and growth.
What we’re looking for We’re looking for someone who brings:
- Education: A Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmacology, or a related life science field (Regulatory Affairs certification is a plus!).
- Experience: At least 4 years in regulatory affairs within the pharmaceutical industry.
- Knowledge: Strong understanding of Health Canada regulations and global regulatory standards.
- Skills: Excellent communication, organizational, and analytical skills, with a keen attention to detail.
You should be proficient in tools such as Microsoft Office 365, Adobe Acrobat, and eCTD Document Management Systems, with the ability to work independently while handling multiple priorities.
Why join us? - Impactful work: Be part of a team that’s dedicated to developing products that truly make a difference.
- Dynamic environment: Collaborate with talented professionals in a fast-paced, innovative setting.
- Career growth: Take on leadership responsibilities and gain exposure to exciting challenges.
Are you ready to contribute your skills and expertise to a role where you’ll make a tangible impact? Apply today to start your journey toward an exciting future in regulatory affairs.
If you are ready to join the team, please connect with us:
Michelle Payne
michelle.payne@archstaffing.ca
#INDR1
About Arch Staffing and ConsultingArch is a diverse and global staffing firm incorporated in 1993. Along with our other divisions, we employ over 20,000 consultants in 72 offices around the world. Arch Staffing & Consulting will be the premier global staffing resource our clients, candidates, and colleagues count on. We focus on finding our candidates their ideal job, and we help our clients find ideal candidates.
Arch provides professional and commercial services for all industries, including information technology, accounting & finance, administration, skilled trades, engineering, healthcare, and industrial.
Our team has more than 100 years of combined experience in the staffing industry, and a large network of proven talent. We have built a culture that attracts and retains the best talent in the industry. At Arch Staffing, placement is just the beginning of the process.
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