Genesis Pharma are currently looking for a Regulatory Affairs Manager to join a leading Pharmaceutical company based in Belgium. Full time position with fantastic benefits available to all employees from day 1 and high competitive salaries.

 

Regulatory Affairs Manager

​

The client is is a biotechnology company specializing in the development of cell therapy products.At the forefront of science and medicine and leader in its field, the Company is developing innovative regenerative products. 
 

To strengthen this growing organisation, the client are now looking for a Regulatory Affairs Manager.

​

You will be in charge of:

​

• Lead of the Regulatory department (Management of the RA team)

• Preparation, writing, review, completion, and update of documents, dossiers and applications for clinical trials and marketing approval (as well as maintenance, renewal, follow-up, and post-approval tasks), including but not limited to scientific advice, protocol assistance, briefing document, CTA, IMPD, eCTD, IND, BLA, NDA, orphan drug designation, PIP, briefing/meeting packages and responses to Health Authorities, safety reports, protocols and amendments, annual reports, and any other regulatory documents.

• Preparation, conduct, and follow-up of submissions to local, national, and international regulatory bodies, such as European national Competent Authorities, FDA, EMA, notified bodies, and Ethics Committees; development of strong relationships and proactive interactions with such regulatory bodies

• Provide regulatory input for and appropriate follow-up to inspections and audits

• Identify, analyze, and communicate regulatory trends, including proposed, new, or changing requirements, as well as current and pending approvals, with review of their implications for the company

• Develop and implement regulatory strategies, programs, and processes, including support in preparation, writing, and update of Standard Operating Procedures and other internal regulatory file documentation, to ensure compliance with regulatory requirements

• Provide strategic input, support, and technical guidance on regulatory issues to development teams

• Relationships: reports to the Director of Clinical Operation

​

Expected profile

​

• Master/PhD in Biomedical Sciences or Pharmacy 

• Minimum of the 3 years experience in Regulatory Affairs environment with a knowledge in ATMP reglementation

• Good knowledge of national and European laws, guidance, and regulatory requirements, 

• Understanding of drug development process, quality systems, clinical trials, and scientific issues in cell therapy

• Strong interpersonal and communication skills 

• Excellent verbal and written communication and presentation skills

• Able to work within a small but quickly growing structure

• Reactive to deadlines, pro-active, dynamic and resistant to stress

• Fluent in French and English; Dutch is an asset.

 

Additional Info

​

• Start date ASAP but willing to wait for right candidate

• Salary to be defined according to profile and experience

• Full time, Long term contract (CDI)

​

​

In order to apply for this role, please forward your most up to date CV and quote the reference number.

​

​

TAGS: Regulatory Affairs