Regulatory Associate III

Together, Let's Make A Difference.

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry's top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking a Regulatory Associate III who will be responsible for providing support for client regulatory submissions. The position will collaborate with internal team members, including those in QA, QC and Manufacturing to maintain compliance with regulatory requirements.

Responsibilities:

• Prepare submissions of license applications and renewals.
• Track and maintain licenses and company submissions as required by applicable regulatory agencies.
• Collect, collate and evaluate data for routine internal and customer regulatory reports.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Prepare responses to customer requests for information.
• Participate as an inspection team member during regulatory inspections.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Embodies Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture.

Requirements:

• Bachelor's degree in a Life Sciences discipline or equivalent experience.
• Minimum of four (4) years of experience in regulatory affairs, QA or equivalent.
• Familiarity with cGMP regulations 21CFR parts 11, 210, 211 and 600, EudraLex Volume 4, cGMP guidelines and good documentation practices.
• Familiarity with fill finish manufacturing batch record structure strongly preferred.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Strong organizational and analytical skills.
• Must be familiar with Microsoft Office applications.

We provide a Total Rewards package designed to make life better - both at work and at home.

• Annual Bonus Opportunities for All Employees
• 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
• Paid Parental Leave
• Annual Company Shutdown in December
• Comprehensive Medical, Dental + Vision
• 401K Company Match + Immediate Vesting
• Backup Daycare and Eldercare
• Monthly Employee Appreciation Events and Food Truck Fridays
• Employee Discount Programs
• Tuition Reimbursement
• Casual Dress Code
• Wellness Programs
• Community Outreach Opportunities

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.