We are currently seeking a Regulatory Specialist to join our growing team. Within this role you will provide a high level review of client programs and work to develop strategic plans for clinical, analytical, and process development.
Reporting to the Assistant General Manager, Regulatory Affairs, you will:
- Develop and execute novel drug regulatory strategy
- Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
- Act as an FDA liaison and support responses to FDA queries. Be the point of contact between the company and the regulatory agency
- Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
- Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
- Have the ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
- Work closely with development team to insure overall regulatory strategy, regulatory CMC strategy, labeling strategy for Pharmaceutical/Biological products are aligned
- Drive risk assessments, identify Regulatory compliance and cGMP needs, implement action plans and train business partners
- Be responsible for product life cycle management and plan for global regulatory filings and assessments as required by the individual project
- Be responsible for implementing new regulatory policies and procedures for effective product onboarding process for private label manufacturing business entities of current engagement
- Initiate, author and/or collaborate on SOP’s, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
- Help strategize a road map for EU expansion: MAA planning (type of submissions – DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and inputs to set up an EU QPPV Office
Desirable Skills and Experience
- 8 to 12 years’ experience working in a regulated, life science environment with strong project management interpersonal skills
- Experience in managing the product life cycle for multiple products (at least a global portfolio of 30 products) along with a team of regulatory professionals
- Able to demonstrate ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK, and EU.
- Extensive knowledge of Global submission standards (FDA, HC, EMA, ICH eCTD etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDA) and Regulatory change management and operations. Knowledge on ROW markets is a plus.
- Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, and Resource Forecasting