Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist (Remote)

Work Location: US – EST, CST, PST time zone. Work from home.

Position Description:

Navitas Life Sciences is pursuing an aggressive growth plan to leverage regulatory, safety and technology and E2E clinical services as a global CRO. Navitas Life Sciences Regulatory practice is in a rapid growth mode and looking for Senior Regulatory Affairs Specialist with Labelling experience to independently lead end to end submission process. This role requires hands-on experience in IND/NDA/BLA submissions and CMC authoring experience for Oncology Products specific to US market.

:

• Work closely with development team to insure overall regulatory strategy, regulatory CMC strategy, labeling strategy for Pharmaceutical/Biological products are aligned.
• Establish sound regulatory advice/position on key development issues and communicate same to the respective stakeholders.
• Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.
• Driving risk assessments, identified Regulatory compliance and cGMP needs, implemented action plans and trained business partners.
• Provide high level review of client programs and develop strategic plans for clinical, analytical, and process development.
• FDA liaison and support responses to FDA queries. Be the point of contact between the company and the regulatory agency.
• Responsible for implementing new regulatory policies and procedures for effective product onboarding process for private label manufacturing business entities of current engagement.
• To 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 & Inputs to set up EU QPPV Office
• Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging.
• Initiate, author and/or collaborate on SOP’s, work instructions and Workflows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in United States, Europe and RoW
• Develop and execute novel drug regulatory strategy.
• Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.
• Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.

Experience and Skills

• Should have 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.
• Experience in Medical device regulations is a plus.
• Working with a team at low-cost delivery centres in India and South America will be an advantage.
• Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & 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.
• 8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.
• Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.
• Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas. Knowledge of eCTD Publishing systems, TRS Toolbox and related tools