Sr. Manager, Regulatory Affairs Gmp

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 Sr. Manager, Regulatory Affairs (RA) who will play a leading role in ensuring the Company’s GXP operations are compliant with U.S. and international regulatory requirements by providing direct oversight to the development, implementation, maintenance, and performance of RA across multiple buildings. This is a leadership role with focus on providing best in class RA support and intelligence internally and for client sponsors. This includes client interfacing support and collaboration. Responsible for sourcing and retaining talent. This position is a key member of cross-functional site leadership, and reports to the Director or Sr. Director of Quality Assurance.

Responsibilities:

• Leads all aspects of Regulatory Affairs for manufacture of commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
• Provides best in class regulatory strategy and guidance for internal operating divisions within the company and for clients. This includes assisting clients in preparation of applications and responds to requests for information to applicable clients and regulatory agencies.
• Serves as liaison between regulatory bodies and operating divisions of the company.
• Establishes and improves Compliance and Regulatory Affairs processes and procedures. Builds depth of knowledge and regulatory intelligence.
• Perform gap assessments and develop mitigation strategies to ensure compliance.
• Maintains current knowledge of regulatory standards to support ongoing business operations.
• Collaborates with internal departments to ensure effective regulatory and customer feedback responses/corrective actions are generated in a timely manner.
• Assists in regulatory inspections including scheduling and task prioritization (US FDA, EMA, PMDA).
• Independently investigates, troubleshoots, and rectifies issues resulting from risk analysis.
• Champions operational excellence (OE) projects for Compliance and continuous improvement.
• Rapidly and accurately communicates issues to Senior Leadership.
• Maintains awareness of recent developments in industry, clients, competitors, and regulatory agencies.
• Ensures that safety standards are maintained.
• 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 required.
• Minimum of 8 years of relevant experience in regulated industry in Quality, Compliance or Regulatory Affairs.
• Minimum of 3 years of functional leadership experience.
• Experience interacting with clients, regulators and senior staff.
• Experience with various phases of commercial drug development (clinical Phase I – III through commercial approvals) required.
• Deep understanding of global drug development and pharmaceutical drug production; minimally 21CFR210/211, ICH, and EudraLex (EU).
• Working knowledge of industry practices, global regulations and experience interacting with multiple health authorities (e.g. FDA, EMA, PMDA, etc.). RAPS certification a plus.
• Effective cross functional collaborator (Manufacturing, Facilities, Supply Chain, Project Management, etc.) and efficient at removing barriers.
• Mindset and proven ability to drive inspection readiness at all times.

Leadership Requirements:

• Directs and provides expert knowledge in the strategic function of Compliance and Regulatory Affairs.
• Develops short and long-term people and organizational strategy in alignment with Aji Bio-Pharma goals and direction.
• Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.
• Identifies, recruits, and retains top-notch talent.
• Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.

The anticipated annual base salary range for candidates who will work in California is $111,135.95 - $155,590.33

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.

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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