Senior Regulatory Writer

Position: Senior Regulatory Writer at Apsida Life Science
Location: Drummondville

Explore a pivotal role as a Senior Regulatory Writer with Apsida Life Science, supporting pharmaceutical clients in North America. Contribute your expertise in regulatory submissions and document management in a flexible 0.8 FTE model.

Apsida Life Science is partnering with an established regulatory writing consultancy. They are in search of a Principal Regulatory Writer to enhance their presence in Canada and the US. This role involves managing client accounts and leading complex submissions, including CTD Module 2, while collaborating with a team known for scientific excellence and strategic insight.

Key Responsibilities:

• Manage project deliverables and client account communication

• Lead high-complexity regulatory submissions and strategies

• Author and review CTD Module 2 documents thoroughly

• Provide scientific expertise and technical writing guidance

• Collaborate with Project Management on budget development

Requirements:

• Degree in Life Science or related field

• Minimum 5 years of Regulatory Writing experience

• Deep understanding of CTD Module 2 submissions

• Proven record as a Senior or Principal Regulatory Writer

Harness your regulatory writing skills in a strategic role at Apsida Life Science to support pharmaceutical innovations.
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