Senior Consultant, Regulatory CMC
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!
Halloran is looking for a Senior Consultant, Regulatory CMC to join its Regulatory Affairs practice area. As a Senior Consultant, Regulatory CMC, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, independently developing regulatory strategies, and leading the preparation, authoring, and review of regulatory submissions. Additionally, you will take a leadership role in interacting with the FDA, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client deliverables and goals.
- Act as a regulatory advisor, regulatory lead, and/or project or program leader for multiple biotech and pharma company engagements; this is accomplished by participating in cross-functional teams in multiple indications and/or product types focusing on Regulatory CMC activities
- Partner with development stage biotech and pharmaceutical companies to guide, develop, and advise on regulatory development strategies and regulatory submissions
- Strategic development planning and support to emerging life science companies pursuing early to late stage development; lead regulatory assessments, integrated development plans, and other strategic planning documents to drive development of clients' assets and platform technologies
- Coordinate, manage, author, and/or review Health Authority meeting documents, special designation requests, and other regulatory submissions
- Lead and manage interactions with Health Authorities on behalf of clients in formal meeting settings, including providing premeeting coaching and preparation
- Coordinate, author, manage, and review sections of IND submissions to Health Authorities.
- Ensure consistent high-quality delivery of client deliverables and goals by working collaboratively with client executives and team members and internal Halloran team members (regulatory operations, clinical, project management, etc.); ensure projects are delivered on time and within budget
- Provide expertise in strategic interpretation of Health Authority regulations, guidance and directives to develop regulatory strategies and sound regulatory submissions
- Effective client management, including assessing and ensuring client satisfaction as well as current and future needs of the client development team; administrative client management tasks such as invoicing, bookings, etc.
- Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
- Contribute to business development efforts, including the authoring of proposals for new client engagements; may independently interact with potential clients in a business development role
- Other duties and responsibilities as assigned
- Bachelor’s degree in a science field with at least twelve years of Regulatory CMC experience in a biotech and/or pharmaceutical setting
- Must have a deep familiarity with current regulatory guidance, GMPs, legislation, industry trends, health care, and business practices in drug development
- Experience in both drug substance and drug product and in multiple product types (small molecules, biologics, etc)
- Regulatory interaction experience with US and ex-US Authorities
- Experience supporting program level strategic planning activities spanning from pre-IND through marketing approval
- Master’s Degree and/or regulatory certifications
- Experience in cell/gene therapy and other innovative development trends is a plus
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Plan for all Full-Time Employees
- Reimbursements for Health & Wellness Programs and Memberships
- Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
- Self-Managed PTO Policy
- Commuter FSA Benefits
Our company is committed to equal employment opportunity. We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.