Hybrid Manager, Regulatory Strategy na Verve therapeutics inc.

The Position

Verve is seeking a Manager, Regulatory Strategy to play a key role in shaping regulatory strategies and ensuring smooth execution of health authority submissions. In this role, you'll collaborate across teams to support early-stage programs, drive regulatory approvals, and keep projects on track. You'll bring a sharp analytical mindset, strong problem-solving skills, and the ability to navigate complex regulatory landscapes. As a key liaison between internal teams and external stakeholders, you'll help communicate regulatory plans, updates, and improvements, ensuring alignment with company goals. This position reports to the Senior Director of Regulatory Strategy.

Job Responsibilities

• Functional responsibilities:
  • Support regulatory and cross-functional teams in planning, preparing, and submitting Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs).
  • Assist in preparing submissions to maintain regulatory applications, including IND/CTA amendments, Development Safety Update Reports (DSURs), and health authority correspondence, while helping to resolve challenges and align stakeholders.
  • Support health authority interactions by assisting in the development of meeting requests and briefing documents and the coordination of meeting preparation, fostering collaboration and addressing shifting priorities.
  • Support regulatory submission processes, timelines, tracking tools, archives, and infrastructure in collaboration with Regulatory Operations, translating functional plans into operational processes and ensuring effective execution.
  • Provide regulatory support to cross-functional teams, contributing to project planning and ensuring alignment with company policies and timelines.
  • Monitor regulatory landscape updates, including health authority guidelines and industry precedents, and share key insights with the team.
  • Contribute to the development of regulatory strategies and process improvements as needed.
  • Work closely with external vendors and internal teams to facilitate project execution and problem-solving in a dynamic environment.
• General responsibilities:
  • Lead projects that drive the company’s goals, ensuring we stay on budget, on time, and on track, while keeping everyone in the loop about potential risks or delays.
  • Spark fresh ideas and dive into data to find the best solutions to challenges.
  • Make decisions with confidence that push both individual and team performance forward.
  • Build strong, trust-filled relationships with teammates and stakeholders, ensuring we’re all aligned and moving in the same direction.
  • Keep everyone informed with clear, concise updates on how projects are progressing and how individual contributions are driving our success.
  • Foster a collaborative, inclusive culture where team members feel valued, motivated, and aligned through trust, strong relationships, and open communication.
• Other duties as assigned.

Qualifications

• Education & Experience
  • Bachelor’s degree in a relevant field; advanced degree (MS, PharmD, PhD, MD) in scientific discipline preferred.
  • At least 5 years of relevant experience.
  • Experience in regulatory strategy, with a strong background in preparing and submitting IND and CTA applications or amendments.
• Skills & Abilities
  • Ability to develop problem-solving skills for complex regulatory challenges, leveraging data and sound judgment to drive project outcomes effectively.
  • In-depth understanding of the evolving regulatory landscape, health authority guidelines, and precedence from relevant external programs. Ability to inform teams about regulatory changes and their strategic implications.
  • Strong presentation skills, with the ability to deliver concise, impactful reports and recommendations to internal and external stakeholders.
  • Excellent verbal and written communication skills to clearly express ideas.
  • Ability to understand and manage both your own emotions and those of others.
  • Skilled in resolving conflicts in a constructive manner.
  • Ability to adapt to shifting priorities.
  • Capable of inspiring and motivating team members.
  • Capacity to provide guidance and constructive feedback to support team development.
  • Ability to recognize and capitalize on opportunities for improvement.
  • Ability to make thoughtful, well-informed decisions that consider the perspectives of the team.