Regulatory Technical Manager

The Regulatory Technical Manager (clinical/non-clinical) has responsibility for strategy development and regulatory review of clinical and non-clinical information This position interacts with all levels in the organization and participates in discussions with management and provides strategic regulatory and clinical/nonclinical guidance. The regulatory technical manager (clinical/non-clinal) interfaces with regulatory agencies, primarily the FDA, as it relates to clinical/nonclinical issues and other relevant topics. The Regulatory Technical manager reports to the Director of Regulatory Affairs. This role does not have any direct reports.

Salary Range: $110,000 - $125,000 per year
Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

• Define and implement regulatory strategies, for products in development related to clinical and nonclinical aspects. Revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc.
• Supports labeling development discussions and leads labeling extensions/updates for NDAs.
• Anticipates and prepares appropriate mitigation strategies.
• Recognizes early developing trends or gaps and brainstorms practical solutions for both short and long-term corrective actions.
• Perform research on other regulatory precedents to support the development of regulatory strategy for the assigned clinical/nonclinical development program.
• Representing regulatory affairs on project teams and providing regulatory guidance and support in drafting clinical/nonclinical submission documents
• Providing expertise in translating regulatory requirements into practical, workable plan
• Applying expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations.
• Interact and uses effective communication to influence regulatory agencies regarding submission strategy.
• Outline and coordinate preparation of and drafting of FDA meeting packages.
• Mentor and coach others regarding the regulatory requirements, including the clinical/nonclinical development phase.
• Managing and prioritizing a diverse individual workload in accordance with departmental goals
• Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
• Possesses and shares expert knowledge of complex issues across Regulatory teams.
• Keep informed on professional and regulatory information and be current on regulatory guidelines and regulations.
• Reviewing technical documents for cGMP and regulatory compliance.
• Ensuring that department management is aware of activities and progress.
• Actively seeks ways to improve team processes and areas for improvement.
• Pursues aggressive goals to deliver on-time business results.
• Demonstrates company core values in daily work.
• Serves as a role model for effectively communicating with individuals in different functions and at different levels.
• Other duties as assigned.

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology, Pharmacology); Advanced degree preferred.
• 8 years of related experience in pharmaceutical within Regulatory Affairs
• Experience in authoring and preparing INDs, A/NDA’s, and Amendments to FDA
• Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals
• Well-developed communication skills
• Excellent organization and interpersonal skills
• Ability to effectively influence at all levels of the organization
• RAC beneficial