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Senior Regulatory Affairs, Belgium - L

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
20 Sep 2022
Closing date
19 Oct 2022

View more

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

Job Details

Description:
Location: Machelen Area, Belgium - Home based

Schedule: Full Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Senior Regulatory Affairs to join one of our clients, one of the most innovative pharmaceutical companies in the world.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.

Scope of the role: Senior Regulatory Affairs, is a position responsible for ensuring the consistent application of regulatory interpretation and implementation for programs such as the European Union - Medical Device Regulation (MDR) and associated secondary legislation within the Cardiovascular & Specialty Solutions Business Units.

Main Job Tasks and Responsibilities:
  • Provides strategic guidance to Cardiovascular & Specialty Solutions (CSS) related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines
  • Ensures the timely execution of regulatory implementation activities and associated projects
  • Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams
  • Educates Franchise Associates on EU requirements and integrates those requirements into Franchise procedures
  • Organizes and maintains reporting schedules, trackers, and systems
  • Develops and sustains relationships with Research Associate affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization, and preparation of responses to regulatory agencies' questions and other correspondence
  • Drives consistency across all businesses within Cardiovascular & Specialty Solutions (CSS) and across MedTech for technical documentation creation and adherence to procedures
  • Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges, and process improvements throughout the program
  • Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
  • Develops and maintains constructive and cooperative working relationships with business functions in the organization
  • Identifies and facilitates continuous improvement activities
  • Represents Cardiovascular & Specialty Solutions in various internal forums
  • Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables
  • Writes, reviews, and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements
  • Responsible for communicating business-related issues or opportunities to the o next management level
  • Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


Education and Experience:
  • University degree in Science, Engineering, Technical or Biomedical field or Law (or equivalent degree with adequate experience)
  • 6-8 years of experience in Regulatory Affairs or other related disciplines in the medical device or pharmaceutical industries
  • Regulatory experience in Chemistry, manufacturing, and controls (CMC) with post-approval variation dossiers for small molecules worldwide preferred
  • 2-4 years of experience in Regulatory Affairs
  • Knowledge of global/worldwide regulatory guidelines and regulations is preferred


Skills:
  • Good knowledge of medical device regulatory requirements in the EU
  • Ability to work effectively in a highly matrixed organization
  • Ability to work autonomously
  • Project Management Skills
  • Strategic thinking and ability to partner and influence key stakeholder's
  • Highly skilled in establishing partnerships with Regional and Franchise colleagues
  • Strong communication, influencing, and presentation skills
  • Strong results-orientated and sense of urgency
  • Strong ability to build constructive and cooperative working relationships
  • Excellent written and verbal communications skills in English (required)


The Application Process

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a 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/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, 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 all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is 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 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.

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: Senior Regulatory Affairs, Regulatory Affairs Specialist, Regulatory Affairs, Medical Devices, Pharmaceutical, Pharma, Permanent, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated.

Skills: Senior Regulatory Affairs Manager, CRO, Medical Devices, Pharma, Pharmaceutical, Regulatory, Regulatory Operations Location: Belgium Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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