Regulatory Affairs Specialist

Contenido de trabajo

Location: Beerse, 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 Regulatory Affairs Specialist to join one of our clients, one of the most innovative pharmaceutical company 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 the client counter-parts.

Main Job Tasks and Responsibilities:

• Strategic and tactical input in development, post-approval and Life cycle management; Drive understanding of central and national regulatory requirements

• Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
• Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
• Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
• Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling
• Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
• Liaison with Regulatory Agencies and Local Operating Companies
• Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
• Determine timing and strategy for Regulatory Agency meetings and scientific advice
• Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
• Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary
• Advise team on required documents and processes to support Regulatory Agency contacts and submission
• Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
• Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
• Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions
• Ensure necessary regulatory activities are planned and adequately tracked in company systems; Clinical Trial Applications (CTA)
• Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
• Advise team on required documents and submission strategies in preparation of CTA
• Ensure CTA submission packages are complete and available according to agreed timelines
• Marketing Authorization Application (MAA)
• Provide regulatory support throughout registration process and life-cycle management
• Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
• Ensure country-specific submission packages are made available to the LOCs

Education and Experience:

• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
• Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
• Experience with EU regulatory procedures (CP)
• Experience in working in project teams and/or a matrix organization
• Previous Pulmonary Hypertension and Immunology experience preferred

Specific Role Requirements and Skills:

• Negotiating and conflict handling skills
• People management skills
• Complex project management skills
• Oral & written communication skills
• Organization & multi-tasking skills
• Excellent knowledge of English
• In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

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 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

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.
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.

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.

Job Types: Full-time, Permanent contract

Benefits:

• Company phone
• Food allowance
• Hospitalization insurance
• Internet reimbursement
• Mileage reimbursement

Schedule:

• Monday to Friday