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Clinical Trial Regulatory Leader, Belgium - L

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
17 Oct 2019
Closing date
4 Nov 2019

Job Details

Description:
Clinical Trial Regulatory Leader

Location: Belgium, Antwerp area

Schedule: Permanent, Full time, Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for an experienced Clinical Trial Regulatory Leader for one of the most innovative pharmaceutical company in the world based in the Antwerp area, Belgium.

For our client facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on projects for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Scope of the role:

This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

Position Duties & Responsibilities
  • Execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial
  • Ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
  • Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country
  • Interact with Health Authorities and act as the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
  • Manage the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system. If Clinical Research Organisations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.
  • Identifiy and proactively respond to issues, problems, or opportunities as it relates to the leading the CTA workgroup. Independently identify the need for and collect information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities
  • Integrate information from a variety of sources, detect trends, associations, and cause-effect relationships and communicate to supervisor, CTA working group and others as appropriate.
  • Propose relevant options for addressing problems or opportunities to supervisor.
  • Make decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA


Qualification & Experience Requirements
  • Bachelor's degree required or equivalent experience
  • Science degree or related experience with pharmaceutical or health sciences industry
  • Knowledgeable with scientific terminology.
  • Minimum 4 years' experience within regulatory affairs in the pharmaceutical industry
  • Experience in regulatory CTA submission regulations and requirements
  • Understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements


Skills
  • Strong communication skills (written and verbal) as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams
  • Strong project management skills (e.g. planning, prioritisation, management of schedules and timelines, detail orientation, strong sense of urgency)
  • Project Management and Leadership skills
  • Ability to lead complex projects and a high degree of problem solving capability required
  • High level of Self-Awareness and adaptability and strong impact and influencing skills.
  • Ability to lead multi-functional teams and build strong, productive relationships across the organisation
  • Ability to work independently


The Benefits of Working for TalentSource 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 facetoface or phone meetings with line manager
  • Full annual performance review process
  • Adhoc 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


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002002

If you would like to discuss the role before applying through the website, please contact Rocio.EgeaMota@cromsource.com for more information.

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsorled 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 clientfacing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highlyqualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good worklife balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity 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.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Clinical Trial Regulatory Leader, Regulatory Affairs, Regulatory, Clinical Trial Applications, Project Management, Pharma, Pharmaceutical
Skills: Submissions Manager, Project Management, Regulatory, Clinical, Pharma, Pharmaceutical 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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