At this moment, we have several Regulatory Affairs opportunities for Freelance professionals:
- CMC specialist
- Regulatory Submission Coordinator
- Regulatory Affairs Manager
Don't hesitate to take a look at our vacancies, maybe you are the specialist we are looking for!
Regulatory Affairs is developed from the desire of governments to protect public health, by controlling the safety and efficacy of pharmaceutical products.
It is important for pharmaceutical companies to supply products that are safe and make a worthwhile contribution to public health and welfare.
As a Regulatory Affairs (RA) Professional you play a crucial role in the lifecycle of a medicine, you guide the drug through all phases of development.
CMC Specialist (Antwerp region + Waloon-Brabant, flexible home-working):
- You are author of the high-quality CMC documentations for HA submission.
- You apply the CMC global regulatory strategies.
- You assure technical congruency and regulatory compliance for the CMC dossiers
- You prepare CMC responses to health authority questions
- You identify content, quality and/or timeliness issues with source documents and propose possible solutions.
- You coordinate the collection of source documentation
- You actively participate as a member of the global Reg CMC team by contributing to the regulatory strategies and identifying/resolving possible critical issues.
- Profile: Advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology,..), Strong CMC knowledge and experience, Fluent in English and Dutch or French.
Regulatory Submission Specialist (Brussels area):
- You will be responsible for the collection and presentation of product registration data to ensure timely registration of new products, new indications and the renewals of established products.
- You will provide regulatory input to the therapeutic project teams located at product development sites for projects to which you will be assigned
- You will interact with European subsidiary regulatory managers in the execution of regulatory strategies and drug registration activities to ensure the earliest possible product license approvals.
- You assist subsidiary personnel by providing scientific support, when necessary, permitting them to be more effective in negotiations with their respective agencies.
- You maintain a sound scientific knowledge and expertise for all assigned products as well as on the European regulatory requirements and environment.
- You will identify and track changes/trends in the medical practice and attitudes within European countries that might impact product and project responsibilities.
- Profile: Advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology,..), At least 1-2 years of experience in the registration process is a must (EU registration is preferable), fluent written and spoken English is required (French or Dutch is a plus).
Regulatory Affairs Manager
- You are responsible for the preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees
- You follow-up the Informed Consent Form development, review and tracking in line with local requirements
- You have an oversight on CRO regulatory activities with respect to clinical trial authorisations, including oversight on (e)TMF maintenance
- You track and report the CTA/IND submission and approval status
- You mainten the public study and study results registries such as clinicaltrials.gov and EudraCT.
- You prepare and follow-up on the Scientific Advice/Protocol Assistance procedures (preparation briefing documentation, slide presentations, meeting minutes, …) at EMA, FDA or country level
- You prepare and follow-up on the Orphan Drug Designation submissions for EMA or FDA
- You prepare and follow-up on the Paediatric Investigation Plan submissions
- You prepare and follow-up on the marketing authorisation applications for EMA, FDA and other Agencies
- Profile: Advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology,..). At least 5 years of experience in the Regulatory Affairs, Good knowledge of regulatory environment for clinical trials in EU, US and other regions (global), Experience in CRO oversight. Fluent in English and Dutch.
- You have a Scientific degree (Chemistry, Pharmacy, Biochemistry, Biotechnology,..)
- You have a strong experience in Regulatory Affairs
- You have excellent communication and organizational skills
- You have an analytical mindset
- You are a team player and you have strong interpersonal skills
- You are able to work independently within your area of responsibilities
- You have an eye for detail and you are meticulous and quality-minded
- You have advanced computer skills
Talent Acquisition Associate
t +3215 21 11 04