Accountabilities:

You will provide senior-level regulatory CMC expertise, supporting the maintenance and regulatory oversight of pharmaceutical products while ensuring activities align with applicable North American requirements. Your responsibilities will include:

Support regulatory affairs activities for small-molecule pharmaceutical products, with a focus on Chemistry, Manufacturing, and Controls (CMC) requirements.

Apply knowledge of the North American regulatory framework to support product compliance and lifecycle activities.

Contribute to processes for maintaining products on the market, including regulatory reporting and ongoing surveillance.

Interpret and assess relevant regulatory guidelines and requirements, translating them into practical recommendations.

Apply an understanding of drug development principles and related regulatory concepts to assigned projects.

Collaborate with internal teams and stakeholders to address regulatory questions and support project deliverables.

Plan, prioritize, and organize work efficiently to meet project objectives and deadlines.

Communicate regulatory information, findings, and recommendations clearly to technical and non-technical stakeholders.

Requirements

The ideal candidate combines extensive pharmaceutical or biotechnology industry experience with strong knowledge of regulatory affairs and the ability to work effectively in a consulting environment. Required qualifications include:

Bachelor's, Master's, or PhD degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs, or another life sciences discipline.

Typically, at least 8 years of experience in the pharmaceutical or biotechnology industry, regulatory affairs, or a related field, or an equivalent combination of education and experience.

Strong knowledge of the North American regulatory affairs framework.

Experience or sound understanding of regulatory requirements and processes for maintaining marketed products, including reporting and surveillance.

Good understanding of drug development and associated regulatory concepts.

Ability to interpret, evaluate, and apply regulatory guidelines.

Excellent written and verbal communication skills.

Strong organizational and time-management skills, with the ability to plan, prioritize, and contribute to multiple tasks and projects systematically.

Ability to work collaboratively and contribute effectively within cross-functional teams.

Additional Preferred Expertise:

Hands-on experience with small-molecule CMC regulatory activities.

Practical experience using Veeva RIM, which is specifically required for this opportunity.

Benefits:

Opportunities to collaborate with international experts across the biopharmaceutical industry.

Access to professional development, career progression, and technical and therapeutic-area training.

Supportive and engaged line management.

Peer recognition and a comprehensive total rewards program.

Exposure to emerging technologies, scientific knowledge, and complex regulatory challenges.

Opportunities to explore different career paths within a growing global organization.

How Jobgether works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

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