Regulatory Affairs Specialist

Job Description

We are currently seeking a Regulatory Affairs Specialist with labeling experience to join our growing team and independently lead an end-to-end submission process. The role will require hands-on experience in IND, NDA, and BLA submissions as well as CMC authoring for oncology products specific to the US market.

Reporting to the Global Head of Regulatory and Safety, within the role, you will:

  • 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 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 the 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 the development team to insure overall regulatory strategy, regulatory CMC strategy, and 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 and inputs to set up EU QPPV Office
  • Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
  • There is a travel requirement of up to 10%

Desirable Skills and Experience

  • Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
  • 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, and NDA) and Regulatory change management and operations. Knowledge of RoW markets is a bonus
  • Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
  • Excellent oral and written communication skills
  • Excellent interpersonal skills
  • Excellent presentation and 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 tools
  • Experience in Medical device regulations is a plus

US - Remote

Graduate/Post Graduate with a life sciences degree

Senior Manager

Regulatory Affairs

Full Time

09 Sep 2022