Senior Scientist Regulatory Compliance

Job Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to :

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Job Overview

The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to develop and implement regulatory strategies to ensure compliance with regulatory standards and client expectations with regulatory filings.

Responsibilities

Qualifications / Skills

Education, Experience & Licensing Requirements

BS, MS or in Chemistry (or closely related discipline). A minimum of at least 3 years of relevant background / leadership in GXP / QA / regulatory compliant pharmaceutical laboratory environment or Quality Assurance / Regulatory Affairs role (prefer late phase / commercial experience). Knowledge of GMP manufacturing and analytical techniques to support QA and Regulatory process. Expertise in creating and interpreting SOPs. Ability to function as technical expert / consultant.

Sedentary work, exerting up to 10 pounds of force occasionally, and / or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability / handicap, genetic information, veteran status, or other characteristics protected by federal, state, and / or local law.

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