Praxis Precision Medicines, Inc.

Compensation

Full Description

Senior Manager, CMC Regulatory Affairs Location: This position has the ability to work remotely with regular travel to the Boston area as needed. Position Summary The Senior Manager, CMC Regulatory Affairs will be responsible for planning and executing the CMC regulatory strategies for assigned development programs. You will partner with CMC technical leads, Quality Assurance, and other technical areas to develop optimized plans for successful regulatory submissions. Primary Responsibilities Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals Align CMC regulatory plans with cross-functional development and manufacturing teams Execute regulatory strategies: track and manage progress within defined timelines Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates Independently and in collaboration with CMC team members, write Module 3 sections to support INDs, IMPDs, NDAs and MAAs. Critically evaluate health authority questions and lead the team of cross-functional SMEs to write responses. In collaboration with CMC team members, write questions and briefing documents in support of Health Authority meetings such as Type C meetings with FDA, and Scientific Advice meetings with EMA. Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes Facilitate the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments Disseminate global CMC regulations and guidelines with appropriate interpretation Education and Professional Preferred Experience Minimum of BS or BA in a scientific or technical discipline, advanced degree preferred. Equivalent combination of education and applicable job experience may be considered Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC responsibilities Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including US FDA and international regulatory requirements (EMA, ICH, Health Canada, LATAM and others), guidance, accelerated regulatory review paths, and policy trends, with expertise in small molecule and oligonucleotide-based product development preferred Proven track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company Experience with Veeva Vault is a plus 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. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. Persistent but polite/respectful in proactively driving change, and able to deal with a diverse group of people with different strengths, skills, and methods of interacting with others while gaining their support. Team player willing to roll up their sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Self-motivated, comfortable with independently making decisions and communicating in a direct fashion, able to 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 Approaches his/her work with professionalism, integrity and personal confidence Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together! Annualized Base Salary $110,000—$130,000 USD 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, at Praxis Precision Medicines, Inc. 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. 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. 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.