Senior Scientist Regulatory Compliance

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.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

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

Provide guidance and input to project teams on regulatory requirements related to document submissions in support of client regulatory filings.

Provide regulatory feedback on new and existing raw material, in-process and product specifications and test methods.

Provide feedback and / or lead project and site risk assessments relative to quality management systems and impact to client projects / regulatory filings.

Obtain, maintain, and manage site registration and accreditation.

Ensure the site is prepared for future challenges and regulatory changes by staying informed about industry trends and advancements.

Serve as key regulatory contact for significant issues and work with cross-functional teams to resolve them.

Manage and carry out product quality review and continued process verification programs. Compile data from paper and electronic sources to complete reports.

Assist with quality records

Including submission of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director, Quality Assurance

Author and Revise Quality Documents where applicable : SOPs and Policies

Assist in preparation and participate in Regulatory Inspections or Corporate / Client Audits when necessary

Qualifications / Skills

Knowledge and Experience in Computer System Validation (CSV).

Knowledge of Electronic Quality Management / Document Systems preferred.

Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.

Track record of successfully applying high level scientific judgment in a variety of complex and unprecedented situations.

Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results.

Ability to transfer job knowledge and skills.

Education, Experience & Licensing Requirements

BS, MS or Ph.D. 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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