Senior Manager, Regulatory Strategy

Position Overview
Praxis is seeking a Senior Manager, Regulatory Strategy to support the development and delivery of science-based, solution-oriented, and internally aligned regulatory strategies. This person will be responsible for the effective management and timely execution of regulatory filings while maintaining compliance with global regulatory standards and commitments.
Role Specifics

• Primary regulatory representative on multi-disciplinary project teams and provide strategic regulatory guidance on development plans
• Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines
• Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments
• Lead or assist in the planning and preparation of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, pediatric plans, NDAs) and coordinate responses to Regulatory Agency requests
• Prepare meeting requests and briefing documents and assure team is ready for meetings and teleconferences with Regulatory Agencies
• Serve as the liaison between the company and Regulatory Agencies for assigned projects
• Develop and maintain knowledge of US, EU and ROW regulations as appropriate for the assigned program(s)
• Keep cross-functional team members apprised of new regulations, standards, policies, and guidelines issued by Regulatory Agencies that may impact the company
• Perform literature and regulatory intelligence searches, prepare reports and assemble documentation to support project teams as required
• Engage cross-functional stakeholders to align on and achieve company and program objectives
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
• Participate in initiatives aimed at improving internal standards and systems

Education / Professional Experience

• Bachelor's degree, preferably in a scientific or technical discipline; advanced degree preferred. Minimum of three to five years in regulatory affairs supporting strategy development and implementation in a cross-functional project team setting. An equivalent combination of education and applicable job experience may be considered.
• Regulatory experience in multiple phases of drug development across various disease areas, with expertise in CNS and small molecule product development preferred.
• Excellent knowledge of regulations, policies, and guidance in the US and internationally related to all phases of product development through to registration and approval.
• Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company.

Other Essentials and Key Success Factors

• Demonstrates a high level of intellectual curiosity, innovation and creative problem-solving with an entrepreneurial spirit; can thrive in an agile environment.
• Ability to think critically with a keen sense of urgency and demonstrated problem-solving abilities.
• Self-motivated, able to influence and guide the work of team members and contribute to a productive and collaborative team environment.
• Highly organized and detail-oriented with a passion to deliver quality results.
• Strong verbal and written communication skills.
• Comfortable with independently making decisions and communicating in a direct fashion.

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide base salary compensation in the range of $162k to $176k. Final salary range may be modified commensurate with job level, education, and experience.
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.