Regulatory Affairs Consultant
Regulatory Affairs Consultant
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Job Description
General information
Publication date
05/04/2025Category
OPERATIONS ENGINEERING/PRODUCTION
Job title
Regulatory Affairs Consultant
Contract
Permanent contract
Job description
ABOUT US
Akkodis is an international engineering consulting and R&D services company. As an innovation accelerator for its clients Akkodis supports leading industry players in the automotive aerospace rail space defense energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies
With more than 55.000 experts in over 30 countries the Akkodis Group is one of the leaders in its field. In Belgium we have close to 1000 experts active in different technical fields.
Job description
As a Regulatory Affairs Consultant you will be part of a team that will be interpreting federal state and international regulations as they apply to products processes practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Sr Manager. You will work in crossfunctional teams with different departments (manufacturing labs QA supply) and collaborate with R&D global regulatory colleagues (Global Chemistry Manufacturing & Controls (GCMC) in order to support the introduction of new products.
Scope of work:
- Support regulatory submissions (CTD BLA NDA) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
- Liaise with regulatory colleagues to communicate and resolve potential issues.
- Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of Pfizer portfolio.
- Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.
- Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
- Contribute to the completion of projects manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.
Business Industry
Life sciences
Profile
Experience:
- Master degree in Life sciences (e.g. industrial pharmacist biomedical sciences bioengineer..
- Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD) with experience in regulatory (authoring CTD BLA) and quality.
- Scientific knowledge analytical skills associated with technical writing skills to issue RFT regulatory documentation
- Knowledge of drug regulations and regulatory guidance of leading agencies (EMA FDA)
- Ability to communicate effectively verbally and in writing good negotiation and influencing skills.
- Dynamic flexible enthusiastic and eager to learn
- Ability to work under minimal supervision and in a team
- Fluent in written and spoken English
- CMC experience is a real asset
OUR OFFER
As an Akkodis consultant you will be:
- In charge of diverse transversal and empowering projects
- Supported in your career by your AkkodisManager
- Actor of your training plan and your personal and professional development
- Member of a dynamic and collaborative community of engineers
- Benefiting from a permanent contract
- Benefiting from a competitive salary packages including several extralegal benefits.
Job location
Europe Belgium Flanders Antwerp
Location
Candidate criteria
Minimum level of education required
6. Master Degree
Level of experience
3 to 5 years
Languages
English 3 : Advanced)
Required Experience:
Contract
Employment Type
Full-Time
