Senior Regulatory Affairs Program Lead - L

ClinChoice
Belgium
Competitive
09 May 2023
08 Jun 2023
HQ00003097
Regulatory Affairs
Full Time
Permanent
Experienced (non-manager)

Description:
Location: Belgium - office 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 Specialist Program Lead 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.

Main Job Tasks and Responsibilities:

  • Provides strategic guidance related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines.
  • Serves as an EU regulatory for the portfolio under his/ her responsibility, supporting daily RA activities.
  • Provides advice, counsel, and expertise on RA issues, both proactively and reactively, to project teams
  • Partners closely with internal partners across the company (including Legal Manufacturers, Importers, Distributors, Marketing, R&D, Regional Regulatory Affairs, Quality Clinical, and Medical Affairs) to ensure that the stakeholders' voices are evaluated within strategies for product launches and product modifications.
  • Critical partner for the International Execution team in the EMEA region
  • Develops and sustains relationships with RA affiliates as their primary point of contact, contributing to the development and execution of local registration strategy. This includes planning, prioritization, and preparation of responses to regulatory agencies' questions and other correspondence for new registrations, product modifications, and renewals.
  • Liaises with the manufacturer to obtain all necessary documents and prepares international documentation to support product registration internationally.
  • Facilitates discussions between EU-based external manufacturers and franchises to support projects in addition to obtaining regulatory documents to support global product registrations.
  • Provides regulatory support for Supply Chain initiatives.
  • Drive input for enterprise regulatory projects
  • 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.
  • Creates and approves Engineering Change Orders pertaining to the Senior RA Program Lead's projects and duties (including but not limited to SOPs, and EU labeling approval)
    Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with applicable regulations (Copy Review Process)
  • Primary Point of Contact for the distribution controls of medical devices in accordance with their regulatory requirements and registration status & support associated processes and system development.
  • Primary Point of Contact for customization activities in the European Distribution Center assuring compliance with global market requirements & support associated processes and system development.
  • Supports announced and unannounced inspections by Competent Authorities and internal functions.
  • Represents CSS (Cascading Style Sheets) in various internal and external forums for the Franchise.
  • Responsible for communicating business-related issues or opportunities to the next management level
    for those who supervise or manage staff, 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, if applicable
  • 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' experience in Regulatory Affairs or other related disciplines in the medical device or pharmaceutical industries
  • Good knowledge of medical device regulatory requirements in the EU

 


Specific Role Requirements and Skills:

 

 

 

  • Ability to work effectively in a highly matrixed organization.
  • Project Management Skills
  • Ability to proactively identify new ideas and solutions.
  • Strong communication, influencing, and presentation skills.
  • A strong results orientation and sense of urgency
  • Skilled in establishing partnerships with regional and Franchise colleagues.
  • Excellent written and verbal communications skills in English and Dutch

 


Our Benefits 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 the 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.

 


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: Regulatory Affairs Specialist, Regulatory Affairs, Pharma, Pharmaceutical, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Medical Devices, MD, Regulatory requirements, international registration, Manufacturers, global product registration, labelling
Skills: Regulatory Affairs Associate, CRO, Labelling, Manufacturing, Medical Devices, Pharma, Pharmaceutical, Regulatory Operations Location: Belgium