Job Ref: 13102
Regulatory Affairs Manager USA (Pharmaceutical)
Reports to: International Regulatory Affairs Manager
We are retained by an international, entrepreneurial, family owned wound and skin care group headquartered in Luxembourg to find a Regulatory Affairs Manager in the USA. This is an exciting opportunity to help bring products to the United States market for FDA approval.
Our client offers patented and reimbursed wound care products, registered as medical devices and sold to hospitals and HCPs. They are seeking a qualified to candidate to help register drugs in the USA.
Duties and Responsibilities
- Responsible for the creation, assembly, and publication of U.S. FDA submissions related to
topical / dermatological drugs and maintenance of these approvals.
- Regulatory project work and timeline planning.
- Adherence to required submission timelines, health authority publishing specifications, relevant legislation and internal working practices.
- Maintaining a productive working relationship with external regulatory bodies (FDA)
- Monitoring external changes to the regulatory environment to ensure continued compliance
- Liaison with several departments in order to ensure that documents are compliant and submission-ready. Work with document authors to ensure that documents comply with current
- U.S. FDA regulatory guidance/template specifications.
- Provision of feedback to your line manager regarding submission progress.
- Ownership of the CTD’s submission.
- Ownership of the first eCTD within the CDER division of the FDA.
- +5 years of experience of Regulatory Affairs in drugs.
- FDA experience is required.
- Chemical background is required.
- Demonstrated experience in eCTD compilation for topical/dermatological drugs for U.S. submissions.
- Demonstrated ability to interact and communicate (both oral and written) with project team/ organizational members/ regulatory bodies (FDA)
- PhD/Master’s degree in Industrial Pharmacy/Pharmaceutical Sciences or equivalent based on relevant experience.
- Knowledge in U.S. FDA drug regulatory requirements, preferably in the field of dermatology.
- (Pre)-clinical background
- Ability to read and understand FDA regulations, guidance documents, test reports and technical/chemical product information
- Submission authoring experience
- Self-motivated team worker who is equally capable of lone working.
- Competitive salary
- A car, laptop, mobile which can be used privately (with limitations)
- A variable bonus based on both Company results and personal performance
- Extensive set of tools to drive your career
- Daily allowances, a solid company pension scheme and attractive collective health insurance package, depending upon your location
- Healthy work-life balance