Sr. Manager, Global Regulatory Affairs (Remote), Temp-to-Perm) (

  • Research & Development
  • Anywhere

12++ month Remote Contract role with strong potential to extend and/or convert to Permanent for the right candidate. Rate is FLEXIBLE depending upon experience.

This role will provide regulatory support to this Pharmaceutical Company’s Global and North American Regulatory Affairs Vaccines Unit.

Lenox Executive Search is seeking an experienced Sr. Manager, Global Regulatory Affairs, to fill an 12++ month extendable remote contractual role with one of the world’s top ten largest global pharmaceutical companies. Must have 7+ years pharmaceutical industry experience is required, with 4+ in Regulatory.

Requirements for the Sr. Manager, Global Regulatory Affairs:

  • Bachelor’s Degree in a science or business-related field is required 7+ years pharmaceutical industry experience is required, with 4+ in Regulatory. Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function).
  • BLA filings, IND & FDA submissions experience
  • Biologics experience a big plus
  • Substantial experience working within Regulatory Affairs with a fluent understanding of drug development.
  • Experience with Vaccines is a big plus
  • Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment.
  • Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/ prepare presentations for management.
  • Analytical and Problem-Solving Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions.
  • Strategic Approach – identifies, create and implement processes for Regulatory Affairs Vaccines that satisfy business objects of the Company globally.
  • Presentation skills – create and deliver presentations with appropriate messaging and focused recommendations.

Responsibilities of the Sr. Manager, Global Regulatory Affairs:

  • Co-ordinates Health Authority submissions and approvals with Regulatory Operations within area of responsibility. Has a quality focus so that submissions are right-first time.
  • Coordinates submissions to FDA, EMA, and Health Canada. Effectively communicates any feedback from Health Authorities and provides analyses of potential impact.
  • Ensures compliance with both internal Company process and policy and regional regulatory requirements with a focus on quality and accuracy in verbal and written communication.
  • Acts as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
  • Accountable for overall content and management of local regulatory components and filings i.e. INDs.
  • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
  • Responsible for US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team