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Regulatory Affairs Ops Specialist Senior

Employer
Hobson Prior
Location
Lessines, België, Hainaut
Salary
Negotiable
Start date
6 Jun 2024
Closing date
4 Jul 2024

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

Job Details

Hobson Prior is seeking a Regulatory Affairs Operations Specialist for a contract role based in Lessines. The successful candidate will be part of the CQA and RA department and will be responsible for ensuring the product registration lifecycle and related processes in Europe This role requires a collaborative individual who enjoys working with internal and external stakeholders.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • Ensure timely preparation submission and follow-up of product variations and renewal applications.
  • Act as a point of contact with local authorities.
  • Respond to inquiries from regulatory authorities in coordination with the Global Regulatory Lead.
  • Manage high-quality labeling translation and artwork.
  • Review promotional materials for compliance with local regulations.
  • Maintain good relationships with internal and external regulatory contacts.
  • Monitor EU and local regulations perform impact analysis where needed and keep internal partners informed.
  • Provide regulatory guidance to business tenders and project teams.

Requirements

  • Bachelor's degree or equivalent in a relevant scientific field.
  • Previous work experience in regulatory or similar role within a pharmaceutical/medical device company CRO or similar organization.
  • Trilingual (Dutch French English).
  • Basic knowledge of Office applications.
  • Good interpersonal and communication skills.
  • Organizational and project management skills.
  • Self-motivated and committed.
  • Certification from Belgian FAMHP is a plus.
  • IT functional knowledge in Veeva Vault RIM & PromoMat TrackWise is an asset.
  • Proficiency in German is appreciated.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
GB

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