Regulatory Compliance Specialist
At our company, we are seeking a skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have expertise in IT systems validation/qualification and GXP regulations (FDA 21 CFR Part 11, EU Annex 11).
Key Responsibilities:
* Ensure the manufacturing IT group operates in compliance with regulatory requirements and internal procedures.
* Develop and maintain policies and standard operating procedures for IT functions.
* Represent the manufacturing IT team during internal and external audits and respond to audit findings.
* Monitor industry trends, identify gaps, and take timely actions to address them.
* Collaborate with global sites to ensure systems meet compliance expectations.
* Perform other duties as assigned by IT management, demonstrating flexibility and a broad understanding of IT functions.
Required Skills and Qualifications:
Qualifications:
* Bachelor's degree in Information Technology or a related field.
* 5+ years of experience in IT compliance/quality assurance within biotechnology or pharmaceutical industry.
* Principal IT Compliance Analyst: 8 years of relevant experience.
* Staff IT Compliance Analyst: 10 years of relevant experience.
* Quality Assurance (QA) experience is strongly desired.
* Experience in the pharmaceutical or biotechnology industry is preferred.
Benefits:
Comprehensive Benefits Package:
* Health and wellness programs including medical, dental, vision, life, and disability insurance.
* Fitness centers.
* 401(k) company match.
* Family support benefits.
* Equity awards.
* Annual bonuses.
* Paid time off.
* Paid leaves including military and parental leave.
Others:
Our Commitment to Diversity and Inclusion:
We believe that our diversity and inclusion make us stronger. We welcome applications from diverse candidates who share our values and commitment to excellence.
Equal Employment Opportunity:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Regeneron has been named one of FORTUNE Magazine's 'Best Companies to Work For' in the US. Our company offers competitive salaries and benefits packages. If you are interested in this exciting opportunity, please contact your recruiter for more information about Regeneron's on-site policy and expectations for your role and location.
Salary Ranges:
For roles based in the US, salary ranges will be provided in accordance with US law and apply to positions in the US. For roles based in Japan and/or Canada, salary ranges will be provided in accordance with local law and currency. Please speak with your recruiter for more information.