Job Title: Director, Regulatory Strategy
Reports To: Chief Regulatory Officer
Functional Area: Regulatory Affairs
Position Location: Remote (possible hybrid)
About Tourmaline Bio, Inc.
We are a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our first clinical trial in Thyroid Eye Disease (TED) in Q3 2023 and plan to initiate additional clinical trials in 2024, one of which is expected to be in cardiovascular disease. More information about Tourmaline can be found at www.tourmalinebio.com.
The Director, Regulatory Strategy reports to the Chief Regulatory Officer, collaborating with the team to build a world-class Regulatory Affairs function from the ground up, from strategy through execution. Primary responsibilities include hands-on management of Regulatory Affairs and strategy, overseeing work performed by outside vendors, and leading groups of internal and external cross-functional personnel to achieve company objectives.
This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior most levels of the organization, while making strategic and tactical impact on the things that matter most – supporting our mission to improve the lives of patients.
- Lead and support the preparation, cross-functional alignment and communication, and implementation of global regulatory strategies for US, Europe and other geographies, as needed, per corporate objectives.
- With oversight from the Chief Regulatory Officer, act as a point of contact to FDA and other regulatory authorities for Tourmaline programs and projects. Liaise, negotiate, and lead relevant FDA, EMA and regulatory authority interactions in other geographies as needed.
- Provide proactive, innovative thinking and risk-based assessment to inform leadership decisions.
- Lead the preparation and coordination of regulatory submissions. Interact across the organization to obtain and/or provide information for regulatory submissions.
- Develop and build strong relationships with Regulatory Affairs team members and regulatory agency personnel.
- Provide Regulatory Affairs representation on project teams and lead or support regulatory sub-teams, ensuring regulatory strategies and information are aligned throughout the organization.
- Accountable for providing timely dissemination of regulatory intelligence, as appropriate to continually educate and inform project teams.
- 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.
- Work with Regulatory, Quality and Technical Operations management to implement internal electronic systems for various documentation workflows.
- Collaborate cross functionally with all relevant areas to support corporate objectives.
- Bachelor’s degree required; advanced degree preferred
Experience and Attributes:
- Minimum 8 years of relevant experience in regulatory submissions for drugs, biologic, and/or combination products with a focus on preclinical and clinical development global strategy and execution
- Experience in Ophthalmology and/or Cardiovascular therapeutic areas a plus
- Fundamental knowledge of eCTD requirements for submission to US and ex-US regulatory agencies (IND, IMPD, BLA, NDA, MAA).
- In depth experience using electronic environments for submissions/documentation management
- Experience preparing for and supporting/attending regulatory agency meetings
- Working knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory submissions and corporate initiatives
- 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
- Excellent analytical, negotiation and drafting skills, with strong oral and written communication skills
- Periodic travel to Tourmaline offices in New York and physical attendance at other project and team meetings may be required.
Base Salary Range:
$190,000 – $240,000, 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 firstname.lastname@example.org. 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.