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

Navitas Life Sciences

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Regulatory Affairs Specialist