Senior Manager, CMC Regulatory Affairs

The Opportunity

The Regulatory Affairs CMC Senior Manager/Associate Director 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’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 as outlined below.  Final salary range may be modified commensurate with job level, education, and experience.