Regulatory Affairs Associate, Belgium - P

Employer
CROMSOURCE
Location
Belgium, Brussels
Salary
Competitive
Closing date
26 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Description:
Regulatory Affairs Associate

Location: Belgium, Brussels

Schedule: Part Time - Office based

TalentSource Life Sciences, a division of CROMSOURCE, is currently looking for a Regulatory Affairs Associate (CMC) to strengthen the team of one of our TOP Pharmaceutical client Companies. An operational role where you will be responsible to coordinate all steps of the registration process on an international level for a number of countries. You will be responsible for the execution of 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 (IMPD's, MAA's…) to regulatory agencies. If you have the experience, you may also act as CMC liaison with regulatory authorities.

Responsibilities:

  • Leads the preparation of CMC information for submission to 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 and Commitments
  • Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities

 


Education and Experience:

 

 

  • University degree, Scientific (minimum PharmD or science related BSc or MSc)
  • Experienced in regulatory CMC or within pharmaceutical development or manufacturing
  • 3-5 years prior international regulatory with experience in CMC or in Quality Assurance
  • Good understanding of drug development/commercial manufacturing of biopharmaceuticals
  • Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation

 


Skills:

 

 

  • Leadership skills, influencing and persuading skills
  • Excellent cross-cultural awareness and understanding
  • Fluency in the English Language is essential
  • Excellent communication, interpersonal and relationship building skills
  • Collaborative team player
  • Excellent planning, organizational and project management skills
  • Proactive and flexible

 


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=HQ00002243

or please contact Rocio.EgeaMota@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.

Keywords: Regulatory Affairs Associate

Skills: CMC, MS Office, Quality Assurance, Regulatory, Regulatory submissions Location: Belgium, Brussels Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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