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Regulatory Affairs Consultant

Employer
i-Pharm Consulting
Location
Puurs, Antwerp, Belgium
Salary
Negotiable
Start date
10 Sep 2021
Closing date
24 Sep 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Startdate: 20/09/2021
Enddate: 31/12/2022

€542.5 per day - maximum pay

As a Regulatory Affairs Consultant, you will be part of a team that will guide our client by 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 cross-functional teams with different Puurs 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 at Puurs site. It is your hard work and dedication that will make our client ready to achieve new milestones and help patients across the globe.


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 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



Experience:

  • Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
  • 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

Service description:

Location: Puurs
Remote: mainly but please consider 1 day on site
Academic model
Min 3 years' experience
Language: English + one local language.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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