CROMSOURCE

Regulatory Affairs Expert, Belgium - L

Company
CROMSOURCE
Location
Belgium
Salary
Competitive
Posted
05 Feb 2021
Closes
25 Feb 2021
Ref
HQ00002449
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences is currently searching for a Regulatory Affair Expert to join one of our partner companies, in Brussels. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.

As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your TalentSource Line Manager.

Main Responsibilities:
  • Execution of European Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications to regulatory agencies
  • Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides
  • Depending on experience, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies
  • Preparation of CMC information for submission to EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans
  • Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements
  • Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff in order to discuss and define regulatory applications (Quality Module, Responses, Commitments)
  • May act as CMC representative in formal meetings and teleconferences with regulatory authorities
  • Life Cycle Teams and compliance of commercial products
  • May operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams


Education, Experience and Skills:
  • Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)
  • Regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain
  • 3-5 years prior international regulatory with experience in CMC or in Quality Assurance
  • Broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects
  • Experience in CMC or Quality assurance
  • Leadership skills, influencing and persuading skills
  • Excellent cross-cultural awareness and understanding
  • Fluency in the English is essential
  • Excellent communication, interpersonal and relationship building skills


Our benefits when working in Belgium:
  • Competitive Salary
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company Car with fuel card depending on the function
  • Dedicated Line Manager
  • Regular face-to-face or phone meetings with line manager
  • Full annual performance review process
  • Ad-hoc team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002449

or please contact Vanessa.Verdickt@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Key words: Regulatory Affairs Expert, CMC
Skills: Pharma, Pharmaceutical, Quality Assurance, Regulatory, Regulatory submissions Location: Belgium Share:

LinkedIn Facebook Twitter Email

Similar jobs

Similar jobs