Current jobs related to Regulatory Affairs Scientist - Niles, Illinois - Jacobs Management Group

As a Regulatory Affairs Scientist at Jacobs Management Group, you will play a pivotal role in a well-established pharmaceutical organization dedicated to producing high-quality branded and generic medications, medical devices, and nutraceutical products. Your expertise will be essential in shaping the regulatory and compliance framework, ensuring that all operations align with FDA standards and guidelines, ultimately contributing to the health and safety of patients.

Key Reasons to Consider This Role:

• Engage in innovative pharmaceutical compliance initiatives.
• Utilize your knowledge of FDA regulations and guidelines effectively.
• Enjoy a competitive salary along with a comprehensive benefits package.
• Access to medical coverage, educational assistance, and retirement savings options.
• Opportunity for professional growth within a rapidly evolving company.
• Collaborate with a supportive and focused team environment.

Responsibilities:

• Oversee and assess current FDA applications to ensure compliance.
• Conduct audits of suppliers and contract manufacturing organizations to verify adherence to GMP and FDA regulations.
• Design and implement strategies to improve regulatory submission processes.
• Establish routine audit programs and compliance monitoring reports.
• Work closely with senior management on matters related to regulatory compliance.

Qualifications:

• Ability to fulfill the responsibilities outlined.
• Proven experience in regulatory compliance within the pharmaceutical sector.
• Familiarity with ANDA/510K processes and supplier qualification/audit practices.
• Strong analytical and problem-solving skills.
• Excellent organizational and communication capabilities.
• In-depth understanding of GMP/GLP/cGMP standards and analytical methodologies.

Application Process:

We encourage interested candidates to express their interest and share their qualifications for this position.