Quality Regulatory Affairs Manager

Location:

Gorinchem – Netherlands

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Engineering Jobs

Other Industries & Skills:

Manufacturing

Advertiser:

Corbion

Job ID:

130997847

Posted On:

23 August 2024

At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.

 

The QRA Manager is responsible for managing and supporting regulatory affairs and related quality activities for the Biomaterials Business unit, ensuring all necessary application filings meet requirements of Regulatory Agencies and Corbion business needs. The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry. The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; EU GMP; EU MDR; ISO 13485 and other applicable regulations including clinical trials regulations (US and EU).

Responsibilities:

-Manage all Quality and Regulatory Affairs relating to regulatory filings associated to the Biomaterials Business Unit and ensure filings meet requirements of Regulatory Agencies. 
-Work with internal/external stakeholders to ensure all Type IV Drug Master Files (DMF) and Device Master Files (MAF) at the US FDA remain current, including filing of amendments, annual reports and management of Letters of Authorization (LoAs).
-Ensure timely responses are provided to requests from Regulatory Authorities, received directly or indirectly, including Information Requests and Deficiency Letters.
-Ensure appropriate communication of amendments of regulatory filings to Regulatory agencies and LoA holders.
-Provide strategic regulatory advice to senior management throughout the development of new processes and products.
-Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations including clinical trials regulations and translate these to the Biomaterials business.
-Provide quality and regulatory support for Strategic projects and to external and internal customers in support of the Biomaterials business strategy. Serve as a project lead for set up or update of Regulatory fillings, as applicable.
-Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations, IPEC guidelines and ISO requirements.
-Provide regulatory compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.
-Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling as assigned.

About you:

-Bachelor’s or Master’s degree in Chemistry, Engineering, Life Sciences or other relevant area.
-Minimum 10 years of experience as Quality professional in pharmaceutical, medical device or other related industries. Relevant certifications (RAC/CQA/CQE) are a plus.
-Working knowledge of ISO 9001:2015, EXCiPACT:2021, ICH Q7, FDA CFR 210/211, CFR 820, EU GMP, EU MDR, ISO 13485 and other applicable regulations.
-Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.
-Working knowledge of clinical trials regulations for pharmaceutical products and medical devices in US and EU.
-Strong written and verbal communication skills, in English. Dutch is a plus.
-Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).
-Proven ability to work cross-functionally to achieve business outcomes.
-Attention to detail, commitment to quality, accuracy, efficiency, and consistency.
-Ability to travel occasionally as determined by business requirements.
 

About Corbion 
 

Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2023, Corbion generated annual sales of EUR1,443.8 million and had a workforce of 2,727 FTE. Corbion is listed on Euronext Amsterdam. For more information: corbion

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.

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