R&D Product Development Director

Nature and Scope

The R&D Product Development Director is a pivotal leadership role responsible for the end-to-end strategy and execution of pharmaceutical drug product development with a primary focus on innovative injectable dosage forms. This role oversees programs from ideation through commercial launch ensuring scientific rigor regulatory compliance and alignment with enterprise growth objectives.

This position requires deep scientific expertise across complex formulations CMC strategy analytical and bioanalytical testing combined with strong business acumen and cross-functional leadership. The Director serves as a key strategic partner in advancing the companys portfolio collaborating closely with Portfolio Management Clinical Regulatory Affairs Manufacturing and Commercial teams to optimize execution accelerate development timelines and pioneer differentiated drug delivery solutions.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Lead the development and execution of comprehensive pharmaceutical development strategies ensuring all R&D programs meet global regulatory standards and corporate objectives.
• Oversee the preparation review and approval of critical pharmaceutical development documentation including Technical Transfer Documents Product Development Reports (PDRs) CMC sections and regulatory submission materials supporting clinical registration and commercial batches.
• Apply Quality by Design (QbD) principles and risk-based methodologies to accelerate development timelines while maintaining scientific excellence and compliance.
• Serve as the scientific authority in Portfolio Management Committee meetings providing technical leadership and strategic input for NDAs 505(b)(2) applications ANDAs and NADAs.
• Maintain expert-level knowledge of parenteral drug delivery technologies and relevant patent landscapes; proactively contribute to intellectual property strategy and differentiation initiatives.
• Develop and execute long-term R&D strategies aligned with corporate growth objectives and emerging industry trends in injectable and complex dosage forms.
• Identify and advance 505(b)(2) opportunities to create differentiated value-added formulations for both new and existing products.
• Partner with Development Medical Commercial Regulatory and Manufacturing teams to build a commercially viable and strategically differentiated product pipeline.
• Contribute to the Scientific Affairs leadership team by shaping and executing the mission vision and operational priorities of the R&D organization.
• Recruit mentor and lead a high-performing technical organization focused on complex generics First-to-File (FTF) and First-to-Launch (FTL) parenteral products.
• Establish and champion robust talent development and succession planning processes fostering a culture of accountability innovation and continuous professional growth.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
• Minimum of 10 years in formulation analytical and process development with a proven track record with complex molecules including solutions lyophilized products suspensions and novel drug delivery platforms.
• 7 years of demonstrated leadership experience managing a team.
• Deep understanding of the drug discovery lifecycle and global regulatory requirements. Experience in a start-up biotech environment and familiarity with advanced drug development platforms would be a plus.
• Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
• Excellent oral and written communication skills.
• Ability to prioritize and perform multiple tasks simultaneously.
• Ability to make decisions independently and with appropriate input.
• Ability to work well in a matrix environment particularly with QA/QC Manufacturing Operations Project Management and Regulatory Affairs.
• Flexibility in adapting to multiple therapeutic areas and/or projects interchangeably.
• Strong computer skills (Word Excel PowerPoint and Outlook).

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

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