Title:
Quality & Regulatory Officer Benelux (temp. 6m)
Company:
Ipsen NV
Job Description:
Are you passionate about ensuring top-notch quality and compliance in the pharmaceutical industry? Do you thrive in a dynamic and collaborative environment? If so, we have an exciting opportunity for you!
Due to pregnancy leave we are looking for a temporarily Senior RQ Officerto join our team at Ipsen Benelux. In this role, you will actively ensure the quality assurance function within our organization. You will oversee the maintenance of product quality and compliance through Quality Assurance and Quality Control functions, as well as manage the Quality Management System and its processes.
As a Senior RQ Officer, you will take the lead on the assigned Specialty Care portfolio, preparing, submitting, and following up on dossiers for marketing authorization applications, variations, renewals, and responses to questions from authorities in Benelux. You will collaborate with Global Regulatory Affairs to develop accurate translations of SmPC, PIL, and labeling within the portfolio. Additionally, you will ensure timely submission, review, and follow-up of packaging materials, update product information on internal and external platforms, and inform third parties in line with regulatory and Ipsen requirements.
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.
Position
Job Title: Senior Regulatory & Quality Officer Benelux
Department & Function: Speciality Care Commercial Operations - Regulatory Affairs & Quality Benelux
Line Manager job title: Head of Regulatory Affairs & Quality Benelux
Location of the role: Merelbeke, Belgium
Purpose of the position
The Senior Regulatory & Quality Officer actively delivers on Regulatory requirements for Ipsen Benelux ensuring smooth launch readiness, product continuity & compliance for the relevant territories: Belgium, Luxembourg, the Netherlands.
She / he actively ensures the Quality assurance function within Ipsen Benelux.
She / he oversees the maintenance of product quality & compliance through the Quality Assurance & Quality Control functions, as well as management of the Quality Management System and its processes.
Main responsibilities and tasks
Regulatory
- Take the Lead on the assigned Specialty Care portfolio part
- Prepare, submit, follow-up up on dossiers for (initial) marketing authorization applications, variations, renewals, responses to questions from authorities in Benelux, in collaboration with Global Regulatory Affairs
- Develop accurate translations of SmPC, PIL & labelling within portfolio
- Timely submit, review, and follow-up of packaging materials (mock-ups), proofreading inclusive, flag deviations vs plan and embark stakeholders in the process
- Timely update product information on internal SharePoint locations, external websites, informing 3rd parties where applicable in line with Regulatory and Ipsen requirements
- Update and ensure correct and complete data in regulatory tracking tools and databases, both locally and at Global end.
Quality Assurance
- Act as Benelux Quality Training Specialist, enrolling Benelux colleagues in dedicated Quality Management System training & compliance tasks Initiate and handle in a timely manner Quality Connect workflows for: 1/ incoming product quality complaints in an accurate manner 2/ deviations and CAPAs, 3/ change control, 4/ audits & inspections records, … and all related documentation activities.
- Ensure dispatch of complained material to production site for QA/QC investigation, and follow-up on investigation outcome for communication internally and towards complainant; reconcile complaints as required for Pharmacovigilance reporting needs Support in the Benelux Quality Management System set-up & maintenance: performing Local SOPs Gap analysis, tracking, revisioning where required, for Inspection Preparedness among others
Act as the deputy Quality Contact for Benelux Provide back-up for the activities as a Responsible Person in Benelux.
Other/General assets
- Handle Ethics related checks and reporting, timely submission of yearly Transparency reporting inclusive
- Keep up-to-date knowledge of relevant legislation and practice
- Maintain a well-organized filing/accurate administrative overview
Experience / Qualifications
- Experience in pharma or pharmacy setting.
- 4 years of experience within Regulatory Affairs, and Quality, in a matrix environment.
- Proven track of GDP/GMP knowledge, and the drive to achieve. GDP trained.
- Fluent, both written/spoken, in Dutch, French, and English are essential to the function.
- Pharmacist preferred.
- Experience in Belgium and NL preferred
Key Required Technical Competencies
- Quality related background (pharmacy, biology, (bio)chemistry, …), GxP trained
- Computer literate & accurate in Word, Excel, PowerPoint etc.
- Regulatory affairs knowledge
- Fast learning capability
Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.