Regulatory Technical Manager

• 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

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.