Manager Regulatory Operations
vor 2 Wochen
Overview:
**Summary**
Responsibility for managing and maintaining existing development and marketing authorization dossiers and compiling submissions in compliance with ICH specifications and Health Authority regulations globally. Co-ordination with functional leads in various disciplines to ensure compliant documents, maintain regulatory information and the physical and electronic regulatory archives, mentor on eCTD requirements and other duties and/or special projects as assigned or required.
This position is to be filled ideally starting February 2024.
**Duties and Responsibilities**
- Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.
- Ensures documents comply with submission ready standards and guidelines and provides guidance with respect to requirements.
- Maintains and archives all regulatory correspondence in appropriate systems.
- Liaises with vendors for submission support, as needed.
- Participates in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.
- Provides expertise and support to the user community for RIM systems and EDMS.
- Maintains tracking tools and systems for regulatory information, including submission content plans.
- Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.
- Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.
- Mentors others on submission processes and requirements and may manage contract Regulatory Operations personnel.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.
- Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports, etc.).
- Participates in the preparation of dossiers containing manufacturing, preclinical, and clinical data.
- Provides guidance to authors for clear document and data presentation and location in order to optimize submission navigation as well as the regulatory review and approval process.
- Co-ordination of packaging and labelling activities between Regulatory Affairs, Regulatory Consultants and Supply Chain.
- Analyze and continuously improve work practices and guidelines and organize and conduct training on behalf of the Regulatory Operations team as appropriate.
- Remain current on knowledge of industry trends relevant to global electronic submissions and interface systems with Health Agencies for all regions managed by the European office.
- Artwork QC of packaging proofs/mock-ups vs. Product Information.
**Requirements**:
- Bachelor degree (in science, technology, health
- related field, or business management preferred) or equivalent experience.
- Minimum of three years’ experience for Manager and five years’ experience for Sr. Manager in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.
- Experience in drug development and knowledge of global regulatory submission content and formats.
- Experience with packaging and labelling, and combination products submissions preferred.
- Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins.
- Excellent organization, communication and writing skills.
- Ability to manage multiple priorities and projects.
- Strong attention to detail and quality.
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