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Regulatory Strategy Director

Connexion Systems + Engineering

Boston, MA

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JOB DETAILS
SALARY
$100–$112 Per Hour
SKILLS
Communication Skills, Compensation and Benefits, Continuous Improvement, Cross-Functional, Drug Development, Drug Products, Establish Priorities, Leadership, Maintain Compliance, Marketing, Presentation/Verbal Skills, Product Lifecycle, Project Planning, Project/Program Management, Regulations, Regulatory Requirements, Regulatory Submissions, Strategic Planning, Systems Engineering, Team Lead/Manager, Time Management, Writing Skills
LOCATION
Boston, MA
POSTED
3 days ago
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Regulatory Strategy Director
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type
  • Duration: contract through 02/2027 (extensions possible)
  • Pay rate: $100 - $112/hr
  • Job Location: Boston, MA (hybrid) -OR- Remote
  • Schedule: Mon-Fri, 1st shift

Description:
We are seeking a Regulatory Strategy Director to lead the development and execution of innovative global and regional regulatory strategies across assigned development programs within a dynamic biopharmaceutical portfolio.

This role will play a critical part in shaping integrated regulatory strategy across the product lifecycle and ensuring alignment between regulatory planning, clinical development, and broader business objectives.

The successful candidate will support a late-stage program and will be responsible for translating complex regulatory, scientific, operational, and business considerations into clear, actionable strategies and implementation plans.

Strong cross-functional leadership, excellent communication skills, and proven experience bringing drug products to market are essential for success in this role.

Key Responsibilities
  • Lead development of regulatory strategy for assigned programs across the full product lifecycle, from first-in-human through post-marketing stages, aligned with global regulatory strategy documents.
  • Serve as the regulatory lead representing Global Regulatory Affairs (GRA) on core development and project teams, ensuring consistent and unified regulatory input across clinical and commercial functions.
  • Provide strategic regulatory guidance and innovative solutions for complex issues, ensuring alignment across cross-functional teams, GRA leadership, and global stakeholders.
  • Anticipate evolving global regulatory requirements and proactively adapt strategies to maintain compliance and development momentum.
  • Develop and shape regulatory strategy for submission packages and health authority interactions.
  • Advise GRA leadership on global regulatory strategy status, risks, and execution plans.
  • Ensure regulatory strategies are aligned with business objectives and compliant with applicable global regulations and guidance.
  • Manage regulatory project plans, timelines, and deliverables to ensure prioritization and timely execution of key milestones.
  • Contribute to continuous improvement initiatives within Regulatory Affairs by providing subject matter expertise and strategic recommendations.

Additional Notes for Candidates
  • Strong preference for candidates with experience supporting drug development programs through approval and/or post-marketing stages.
  • Must have demonstrated ability to lead cross-functional teams in a highly matrixed environment.
  • Excellent written and verbal communication skills required.
  • Selected candidates will be required to sign an NDA prior to interview (via electronic signature).

 

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/