Job Description

Who are we?

---------------

Amaris Consulting

is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.



At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call

: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

(the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study

: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.




As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.


We look forward to meeting you!

Job description

-------------------

We are seeking a

CMC Regulatory & Technical Documentation Specialist

to join our team in Toronto. In this role, you will be responsible for managing and preparing CMC (Chemistry, Manufacturing, and Controls) documentation, ensuring compliance with regulatory requirements for

Bioprocess Development, IND, and CTA submissions

. You will collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to develop high-quality technical documents that support our biopharmaceutical projects.


###

Key Responsibilities

Manage and coordinate

CMC documentation

for

IND and CTA submissions

, ensuring alignment with global regulatory requirements. Develop, review, and maintain

high-quality technical documentation

related to

Bioprocess Development, GMP Manufacturing, and CMC data

. Ensure regulatory compliance by preparing

Module 3

(CTD/eCTD) submissions and supporting post-approval changes. Work closely with

R&D, Manufacturing, QA, and Regulatory Affairs

to ensure accurate representation of data in submissions. Identify opportunities for

process improvements

in CMC documentation and regulatory submission strategies. Maintain compliance with company policies, SOPs, and international regulatory guidelines (FDA, EMA, Health Canada, ICH Q8-Q10).
###

Requirements

Education

: Bachelor's or Master's degree in

Biotechnology, Biopharmaceuticals, Life Sciences, Engineering, or a related field

.

Experience

: Minimum

3-5 years

of experience in

CMC regulatory affairs, technical documentation, or bioprocess development

within the pharmaceutical/biotech industry.

Regulatory Knowledge

: Strong understanding of

IND, CTA, and other regulatory submission processes

, including knowledge of

FDA, EMA, and ICH guidelines

.

CMC & Bioprocess Expertise

: Experience in

biopharmaceutical development, GMP manufacturing, and technical writing

related to process development.

Technical Writing Skills

: Proficiency in preparing high-quality regulatory and technical documents, particularly for

Module 3

submissions.

Collaboration & Organization

: Ability to work cross-functionally, manage multiple projects, and meet strict regulatory deadlines. *

Software & Tools

: Familiarity with

eCTD software, Veeva Vault, Documentum, or other document management systems

is a plus.