*Sr. Manager Regulatory Compliance
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AGC Biologics Copenhagen is establishing a new Regulatory Compliance team and we are looking for a new colleague. If you like continuous development and growth, AGC Biologics is the place to be. Our Quality Area is expanding, and we are looking for a diligent and customer-oriented Regulatory Compliance Sr. Manager to join our team.
About Regulatory Compliance in AGC Biologics Copenhagen
AGC Biologics is growing - we are building a new facility next to our existing facility in Copenhagen. We have more commercial customers and late-stage clinical projects that require a strong knowledge of regulatory compliance and the support we need to provide to our customers.
We have established a new group within the quality organization to support this. The Quality Organization consists of +250 dedicated Employees in 5 departments Quality Assurance, Quality Control, Quality Systems, QP Release, Validation and Regulatory Compliance.
Our Quality Management System is based on EU GMP Vol 4 and relevant Annexes, FDA 21 CFR Part 210, 211 and relevant ICH guidelines. We are inspected frequently by DMA, FDA and other international regulatory agencies based on our customers filing strategies.
In Regulatory Compliance we will focus on:
-
- Customer Assistance for regulatory filings such as IND, BLA etc.
- Support regulatory strategies for new and existing products.
- Ensure knowledge of customer regulatory filings are implemented in our quality documents.
- Ensure Regulatory Intelligence and support implementation of regulatory updates.
- Provide critical review of applicable documentation supporting customer regulatory applications, provide gap analysis based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management.
- Interact with regulatory authorities and respond to inquiries
- Monitor and analyse regulatory developments and communicate changes to internal and external stakeholders
- Provide guidance and support to cross functional teams within AGC and externally on regulatory matters
- Routinely interface with internal and external partners to coordinate regulatory inspections and assist in responses to observations.
- Routinely interface with internal and external partners to coordinate regulatory inspections and assist in responses to observations.
- Work with AGC Departments to ensure regulatory understanding, carry out gap assessments and risk assessments.
- Drive collaboration across site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution.
- Implement key inspectional processes such as compliance risk assessment, presenter and inspection staff training.
- Support management of customer quality agreements and support cross-functional review.
- Set-up of an infrastructure to track customer filings to enable an overview of the regional differences of the customer filings.
- Support our quality organization in training SMEs in regulatory knowledge.
- Support with regulatory knowledge in investigations and closure of Critical and Major deviations and Change Controls.
- Be an active partner in our Quality Change Boards.
The team is new and you will be an essential person in defining the team objectives. Currently we are 2 persons in the team both with +20 years of experience within quality. You will be an essential part of defining the teams objectives and you will be able to network with other Sites in AGC Biologics in EU, US and Japan.
Your profile:
You are passionate about compliance and have a deep knowledge of regulatory practices and requirements. You have direct experience supporting multiple functions in a pharmaceutical or a regulatory industry and have experience participating in inspections.
Education/Training:
- Master’s degree in Life Sciences, Natural Science, PhD, or equivalent.
- A minimum of 5 plus years’ experience required working in the Pharmaceutical industry or regulatory space.
- Strong regulatory experience is required.
- Strong familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies and guidelines.
- Detail oriented with strong organisational skills
- Ability to work independently and as part of a team
Soft skills and Competencies:
- Positive, solution oriented “can-do” attitude. You like to work with people and to leverage knowledge of regulatory requirements.
- Strong written and verbal communication skills
- Actively develops and maintains strong professional relationships building trust and respect across the organization.
- Lead through influence, effectively build alignment and collaborate with multiple stakeholders.
- Assess performance roadblocks and develop appropriate solutions.
- Facilitate organizational change related to quality systems across multiple functions.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
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Jobbet er oprettet på vores service den 12.6.2023, men kan have været deaktiveret og genaktiveret igen.
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