Responsibilities:

Report directly to the VP of Regulatory Affairs & QA:

Establish and maintain direct communication channels with the Vice President of Regulatory Affairs & Quality Assurance.

Active participation in the preparation and update of a regulatory strategy:

Collaborate in the development and refinement of regulatory strategies specifically tailored for the combination drug-device, aimed at securing clinical development plan and FDA/OUS approvals.

Manage the clinical trials application submissions in the US, Canada, EU, and other territories:

Work in collaboration with the CRO and other stakeholders of the company pertaining to the clinical trial.

Compile and review all regulatory-related documentation of the clinical trial (e.g.: IMPD, IB, CTA).

Provide responses in due course on queries from Competent Authorities and Ethics committees, clinical trial protocols, Investigational Brochures, briefing books, and requests for meetings with Health Authorities.

Oversee regulatory writing for submissions:

Supervise and contribute to the development of regulatory documents essential for submissions, ensuring accuracy and compliance.

Track, interpret, and provide advice related to US/ EU regulations within the scope of the company product (drug/ device combination product)

Coordination and lead of IND, and NDA submission package. Work closely with external regulatory consultants on the preparation, compilation, and submission of regulatory applications for approvals.

Represent and be the focal point of the company RA-clinical in all internal and external meetings with stakeholders, deliver accurate status reports to VP RA to enable accurate planning and decision making.

Requirements:

Possess a minimum of 10 years of experience in pharma companies or in a combination of drug-device companies conducting phase II/phase III clinical trials.

Demonstrated expertise in INDs/NDAs/sNDA regulatory applications to the FDA or same-level applications to EMA.

Excellent know-how in submitting documentation pertaining to the above-mentioned phase II, and phase III clinical trials.

High regulatory writing skills for regulatory submissions.

Demonstrated experience in regulatory strategy development.

Holds MSC Degree in Life Science discipline.

Possess excellent regulatory writing skills in English.