Reports To: Senior Director, Regulatory Strategy
Job Title: Regulatory Project Manager
Functional Area: Regulatory Affairs
Position Location: Remote (possible hybrid)
The Regulatory Project Manager reports to the Senior Director, Regulatory Strategy and provides project management leadership to key US and global regulatory submissions across Tourmaline’s pipeline. Primary responsibilities include hands-on management of all aspects of Regulatory Affairs project management, including establishing and managing timelines for key project milestones, participating in Regulatory submission teams, monitoring submission deliverables, identifying risks and mitigation strategies, coordinating project team meetings, and monitoring and reporting on project status.
- Collaborate with Regulatory Affairs leadership in establishing and managing timelines for key project milestones, adhering to processes and documentation, and communicating with cross-functional teams and key stakeholders within Tourmaline and with external partners to ensure the delivery of business objectives.
- Participate on Regulatory submission teams, providing project management expertise in the end-to-end planning, coordination, and execution of assigned Regulatory submissions and project deliverables.
- Monitor submission deliverables as required to support investigational (IND/CTA) and marketing applications (BLA/NDS/MAA), and global clinical trials as required.
- Work with key stakeholders for major submissions, identifying risks, opportunities, and mitigation strategies, ensuring successful and on-time project execution.
- Provide project management support of the preparation and contribution to regulatory agency interactions and submissions.
- Define, develop, and execute project plans specifying goals, strategy, resources, scheduling, risks, and contingency plans.
- Support assigned projects and programs including coordinating project meetings, updating project documentation, and monitoring project status.
- Provide Regulatory Affairs representation on project teams and lead regulatory sub-teams, ensuring regulatory strategies and information are aligned throughout the organization.
- Maintain a high level of regulatory knowledge and provide regulatory advice to program teams, internal and external partners on development assets and the broader organization.
- Collaborate cross functionally with all relevant areas to support corporate objectives.
- Bachelor’s degree required; MS, MBA and/or PMP desired.
Experience and Attributes:
- A minimum of 5 years in drug, biologic and/or combination products in Regulatory Affairs and 3 years of experience performing directly relevant Regulatory Project Management activities within the pharmaceutical and/or biotechnology industries.
- Experience in Ophthalmology and/ or Cardiovascular therapeutic areas a plus.
- Familiarity with Regulatory framework and understanding of the overall drug development process for both early and late-stage programs in US and Europe (IND, CTA, BLA, NDA, MAA). Global experience a plus.
- Experience in participating on Regulatory submission teams with ability to look across multiple programs for submission related conflicts or resourcing constraints.
- Ability to identify and document all regulatory project deliverables from each functional area for global regulatory submissions. Maintain detailed timelines for global regulatory strategies in the US and other countries/regions; ensure proactive planning and coordination of activities via the submission project teams.
- Thorough working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.) and global eCTD submission requirements.
- Strong interpersonal, communication, organizational/planning, and time-management skills.
- Detail-oriented with ability and desire to work in a fast paced, team oriented, small company environment, with the ability to manage simultaneous priorities and challenging deadlines.
- In depth experience using electronic environments for submissions/documentation management.
- Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required.
- Excellent interpersonal skills, strategic thinking, high emotional intelligence and the ability to develop important relationships with key stakeholders across disciplines.
- Periodic travel to Tourmaline offices in New York and physical attendance at other project and team meetings may be required.
Base Salary Range:
$124,000 – $148,000, based on candidate professional experience level.
If you have a passion for our mission at Tourmaline, we would love for you to join our team. To apply for any of our open positions, email your resume to email@example.com. Be sure to include the title of the position of interest in your email.
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.