OPPORTUNITY
JOB
Regulatory and Quality Assurance Officer
Description of the function
In this role, you will mainly:
- Contribute to the maintenance and development of Belpharma product regulatory
dossier.
- Interface Belpharma towards the regulatory authorities in various countries where our
products are registered.
- Contribute to strengthen the company Quality structure and processes.
In the current COVID crisis situation, this role can be fulfilled for around 60% of the time from
home, the remaining 40% requesting your presence in the office.
To this end, you will concentrate mainly on:
Regulatory Affairs (RA) – 45% of your time
o Keeping up to date with changes in regulatory legislation and guidelines mostly from
EMA perspective.
o Compiling and maintaining regulatory documentation databases for all RA activities.
o Coordinate efforts associated with the preparation of regulatory documents or
submissions.
o Maintaining familiarity with company product portfolio.
o Communicate with regulatory agencies regarding pre-submission strategies, potential
regulatory pathways, or clarification and follow-up of submissions under review.
o Outlining requirements for labelling, storage and packaging.
o Communicate with EMVO (European Medicines Verification Organisation) and national
MVOs regarding serialization.
o Ensuring the company, as MAH, complies with all its obligations with regards to
applicable regulations.
Quality Assurance – 35% of your time
o Preparing and implementing quality assurance policies and procedures (SOPs).
o Conducting regular trainings for employees for Quality related SOPs.
o Ensuring that standards and safety regulations are observed in our contract
manufacturing partners (ex: audits and quality agreements).
o Addressing and discussing quality issues and proposed solutions.
o Documenting quality assurance activities such as change control, deviations, PQRs,…
o Planning, undertaking and overseeing quality inspections which can be by external
partners, authorities, or internal audits.
The rest of your time (20%), will be dedicated to documentation and archiving management for
the company.
All your actions are in accordance with Belpharma growth objectives and within the scope of
the agreed strategy, working practices & ethics and business value. You will receive clear
objectives and you will be assessed through our Performance Management Plan (PMP) by
your N+1.
In this role, you report directly to the Technical and Clinical Manager.
Your profile
- You are holder of a university degree such as chemistry, biochemistry, biotechnology,
pharmacy, medicinal chemistry, biomedical science, life or applied science.
- You have at least 2 years of experience in pharmaceutical industry.
- English is a must, French and/or any other language is a plus.
- Good knowledge of software packages including Microsoft Office Suite (especially
Excel and PowerPoint).
- High degree of autonomy and anticipation, ability to set up priorities and follow on
deadlines.
- Very well organized, accurate to your daily work and reliable.
- You have a high degree of business ethics: High performance without ethics has, for
us, no value.
We offer
- A unique opportunity to work in a lean, fast deciding company, start up mode, where
you will be in the driving position to build the business.
- A full time long term contract.
- A competitive salary package according to your competences and your commitment,
completed by attractive extra-legal advantages.
- A dynamic and modern working environment.
Working place
2, rue Albert 1er L-1117, Luxembourg,
GD of Luxembourg
Interested?
We are looking forward to meeting you soon!