Global/US Regulatory Strategy Lead (Snr Manager / Associate Director & Director levels) - Cardiology - USA - Tri State (code USA 071220-2)

Reference: RS071220R

Expiry Date: 21-09-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

Global/US Regulatory Strategy Lead (Snr Manager / Associate Director & Director levels) - Cardiology - USA - Tri State

Location Tri-State USA

I would definitely describe this organisation as one of my most dynamic clients!  They have a fantastic pipeline of Cardiovascular, Oncology, Immuno-Oncology & Immunology products and due to the continued growth and expansion of their pipeline and marketed products portfolio they  have a number of Global Cardiovascular Strategy Lead positions open for both US and Global markets, covering all major territories and regions including US, EU, Japan, China and Canada.

The Cardiovascular portfolio can easily be described as being diverse, broad-based and varied, and this role will offer you the opportunity to work on at least 2 different indications in development, providing you with a wide variety of activities and interesting challenges as the regional and/or global lead.  In return they offering really interesting career pathways and great opportunities for further development in both regional and global regulatory teams and the option to move into Oncology or Immunology at a later date, in a global role.

Regarding compensation, they are really open, and will pay well to get the right candidates, they will also cover any loss of bonus and cover loss of stock.  They are flexible and relaxed about home working during COVID and post COVID will be flexible on days worked in the office or from home (normally a 50/50 split).

Regarding compensation, they are really open, and will pay well to get the right candidates, they will also cover any loss of bonus and cover loss of stock.  They are flexible and relaxed about home working during COVID and post COVID will be flexible on days worked in the office or from home (normally a 50/50 split).

This Client has a very promising and diverse pipeline in cardiovascular, immunology, hematology & oncology with a vision to be at the forefront of transforming patients lives through science, They are passionate about the change they bring to patients lives.

Job Description

Responsibilities:

  • Leadership responsibility for global regulatory strategy within a development team (DT).
  • Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. 
  • Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
  • Prepare content for regulatory strategic documentation and Regulatory Project Reviews.  Align regulatory plans with commercial and development plans
  • Develop target labeling and co-lead the cross-functional labeling team.
  • Ensure consistent positions are presented in responses to global health authority (HA) queries.
  • Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. 
  • In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
  • Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
  • Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Required:

  • Scientific background with a minimum of a Bachelor’s degree (PhD, MD, PharmD, Masters, desired) and 4+ years of relevant experience in Regulatory Affairs.
  • Understanding of scientific content and complexities and good knowledge of Cardiovascular drug development is desired.
  • Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
  • Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
  • Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
  • Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
  • Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
  • Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
  • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
  • Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
  • Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
  • Experience utilizing leadership techniques to drive a team through the stages of team development.
  • Other Qualifications:
  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
  • Communicates opinions, facts and thoughts with clarity, transparency and honesty
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • Looks for opportunities for continuous improvement.

 

To Apply!

To apply, or if you would be interested in learning more, please contact me, Roland, via email roland@AdvTalent.com  or via phone 855 505 1382. Alternatively, please press the red “Apply for position” button and follow the registration process.

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