Job Title: Regulatory Affairs Senior Associate / Specialist
Work Location: Boston, MA US
Reports To: Practice Head - Regulatory
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 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.
Job Description:
- Develop and manage day-to-day operations using 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
- Provide high level review of client programs and develop strategic plans for clinical, analytical, and process development
- Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
- Author BLA/IND/NDA and other applications for submission, as required
- Initiate, author and/or collaborate on SOP’s, work instructions and Workflows for the regulatory operations function. e.g., Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in US, Europe, and Row
- 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
- Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison
- 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
- Support delivery in performing project management activities or as individual contributor for a deliverable, managing relationships with all stakeholders
Qualifications: Graduate/Post-Graduate with a life sciences degree (Preferably Regulatory Affairs domains or equivalent)
Required Knowledge and Skills:
- Knowledge in IND/NDA/BLA submissions and lifecycle submissions for US Markets
- Should have handled Oncology Products with CMC experience
- 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 of ROW markets is a plus
- Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
- Excellent oral & written communication skills
- Excellent interpersonal skills
- Excellent presentation & persuasive skills
- Self-driven – Needs to have the ability to work with minimal supervision
- Ability to relate to technology in Regulatory domains
- Knowledge of eCTD Publishing systems, TRS Toolbox and related tool
- Experience in Medical device regulations is a plus