Senior Manager - CMC Regulatory Solutions, Ahuntsic North

Job Description We are a technology‑led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future‑ready. We offer accelerated, global growth opportunities for talent that is bold, industrious, and nimble.

We provide a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.

Must Have Role: Senior Manager specializing in CMC Operations and Writing.

Education: Minimum of a Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline. Plus relevant Master’s degree.

Experience: 16–18 years of overall experience in CMC operations, writing, and a strong familiarity with regulatory expectations across development stages.

Role Purpose: To lead, build CMC expertise, and oversee a growing CMC writing team within our Regulatory Services business. This leader will be responsible for internal team management and client‑facing strategic CMC consulting. The ideal candidate brings hands‑on CMC expertise, including preparation of CMC documentation, and is confident, poised, and can lead client engagements. The role will shape best practices for CMC content generated via our AI platform.

Knowledge and Skill Requirements

Extensive experience in CMC operations, writing, and familiarity with regulatory expectations across development stages.

Proven leadership experience at Manager, Senior Manager, or equivalent level.

Experience presenting scientific data to internal leadership or external partners.

Ability as a consultant‑level subject matter expert interacting directly with clients.

Track record of managing or collaborating with manufacturing sites, QC/QA teams, CROs and other cross‑functional stakeholders.

Strong communication skills with strategic and operational aspects of CMC projects.

Strong business acumen and financial understanding of various business models.

Responsibilities

Lead, mentor, and expand a global team of CMC medical writers/experts; establish team structure, processes, and standards.

Represent the CMC team as a senior subject matter expert in client meetings, including regulatory strategy discussions and project scoping.

Provide expert input into solutions, assumptions, demand estimates, and costing for client proposals; participate in leading pitch meetings.

Oversee quality of CMC deliverables; ensure quality, timelines, and compliance with performance metrics and specifications.

Contribute hands‑on writing or review as needed for high‑priority clients or complex CMC documents.

Serve as strategic advisor on AI‑generated CMC outputs; drive development of CMC outputs by generating and reviewing documents from the AI platform and working with the AI development team.

Collaborate with Regulatory Strategy, Operations, Manufacturing, Go‑to‑Market, and AI platform teams to ensure unified delivery across projects.

Location Requirement Applicants must live in the United States or Canada and be authorized to work for any employer. This position is either fully remote or hybrid remote, depending on location.

Good to Have

Experience shaping or evaluating AI‑assisted document workflows and outputs.

Knowledge of building new service lines or operational structures within regulatory writing.

Ability to work in fast‑paced, ambiguous, or start‑up‑like environments while shaping new capabilities.

Experience working with international team members.

EQUAL OPPORTUNITY Compensation&Benefits Transparency Statement

Base Salary Range:

$150k‑$185k

The compensation range displayed reflects the full span of pay across all of our U.S. geographic pay areas and experience levels.

Your actual base salary offer will be determined based on multiple factors, including:

Geographic Pay Area

(US 1 through US 5)

Experience&Qualifications

relevant to the role

Internal Equity

alignment with employees in similar roles and levels

What This Means for You

The minimum of the posted range represents the starting point for candidates in the lowest cost‑of‑labor pay areas (US 5).

The maximum of the posted range represents the upper threshold for candidates in the highest cost‑of‑labor pay areas (US 1 / US 2).

Candidates are aligned to pay areas based on their primary work location.

For Current Employees

Posted salary ranges reflect the full compensation band across all U.S. pay areas and experience levels. Your individual compensation is based on your specific pay area, hire date, performance trajectory, and internal equity.

Benefits Overview

This role is eligible for a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; a 401(k) retirement plan; seven sick leave days, vacation paid time off, and paid holidays; all in accordance with Company plans.

Indegene is committed to pay equity and transparency. We regularly benchmark our compensation against market data to ensure competitive and fair pay practices across all locations.

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions will be based on business requirements and applicant merit.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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