Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Regulatory Specialist who is responsible for providing support for all internal/company and external/client regulatory-related activities. The position will collaborate with internal team members, including but not limited to those in QA, QC and Manufacturing to maintain compliance with regulatory requirements.

This position is located in San Diego, CA.

Responsibilities:

• Identifies relevant guidance documents, international standards, or consensus standards and provide interpretive analysis.
• Obtains and distributes updated information regarding domestic or international laws, guidelines, or standards.
• Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Provides technical review of data or reports for regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Prepares submissions of license applications and renewals.
• Tracks and maintains licenses and company submissions as required by applicable regulatory agencies.
• Collects, collates, and evaluates data for routine internal and customer regulatory reports.
• Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Prepares or maintains technical files as necessary to obtain and sustain product approval.
• Prepares or directs the preparation of additional information or responses as requested by regulatory agencies.
• Prepares responses to customer requests for information.
• Participates 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 required.
• Minimum of 4-6 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 proficient with Microsoft Office applications.

The anticipated salary range for candidates who will work in California is $65,526.54 - $86,003.58

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

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 be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

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.

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