Sr Manager/Assoc. Director--Regulatory Affairs
POSITION: Sr Manager/Assoc. Director--Regulatory Affairs
LOCATION: Bavarian Nordic Inc.--Morrisville, North Carolina--USA
Responsible for assisting with the development
and implementation of regulatory strategy of medicinal products and regulatory management of projects and teams through product development, registration processes and life-cycle management.
Responsibilities include, but are not limited to:
- Assist with development of regulatory submission strategies.
- Registration Applications (Marketing Authorization Applications, Clinical Trial Applications): Management, compilation, submission and processing of registration applications for designated projects.
- Ensure that registration applications are of high quality and submitted in due time to the competent regulatory agency consistent with the company’s strategic goals for manufacturing and marketing.
- Timely management and preparation of high quality eCTD ready regulatory documents (e.g. Health Authority briefing packages, target product profile, summary of product characteristics, Prescribing Information, Investigator’s Brochure, Development Safety Update Reports).
- Regulatory Life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual products, facility/product registrations).
- Inform regulatory authorites without delay of reported adverse reactions/side effects pre- or post-approval in cooperation with drug safety.
- Represent Regulatory as member of Project Team(s) and assure RA input into designated projects.
- Preparation of periodic (monthly) status reports on the regulatory aspects of the designated projects as necessary.
- Maintain regulatory expertise and serve as internal consultant on relevant regulations and guidelines, current regulatory environment and regulatory precedent.
- Review of quality, nonclinical, and clinical documents for scientific and regulatory compliance.
- Establish effective working relationships with internal and external customers, including Regulatory Agencies.
- Supervise and mentor direct report(s) and work closely with external consultants.
- Serve as primary/secondary liaison with US regulatory authorities (FDA/NIH OBA).
- Provide strategic writing and review input into regulatory submission documents.
- Ensure preparation of high quality regulatory documents and submissions.
- Advanced life science degree (MS, PhD) with 8-10 + years of regulatory affairs experience.
- Advanced knowledge of drug development process, regulatory submissions and approval processes.
- Involvement in IND/CTA submission and approval.
- Experience in the development and registration of biologics.
- Knowledge of domestic and international guidelines.
- Proven direct interactions with FDA and familiar with at least one other major Health Authority (i.e. Europe, Canada).
- Excellent written and verbal communication skills, decision making, and analytical abilities.
- Experience with oncology therapeutic area and knowledge of vaccines and immunotherapy products highly desired.
Please send resume/CV to firstname.lastname@example.org