This Bay Area pharmaceutical company is developing and commercializing innovative therapies for women’s health and prostate cancer. They just received FDA approval for their first drug, and will be filing another NDA next year. They are seeking a Regulatory CMC Senior Director or Executive Director who can lead the CMC regulatory function and manage the team. This company offers an incredible company culture, competitive compensation, equity, and great employee benefits. Now is an exciting time to join this rapidly growing organization and bring new products to market!
Key Responsibilities
- Oversee the development and execution of CMC Regulatory strategies for a portfolio of drugs in development and approved products.
- Work closely with colleagues to develop CMC regulatory submission strategies, review content, and maintain submission timelines to meet business objectives.
- Proactively identify regulatory CMC issues and provide solutions to keep assigned programs on time, while maintaining the highest quality.
- Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, CTAs, NDAs and MAAs.
- Manage and lead a team of Regulatory CMC professionals.
- Represent CMC Regulatory Affairs submission teams, creating timelines and plans for complete and accurate submissions.
- Prepare for Regulatory Agency meetings with CMC focus.
- Liaise with Medical Writing for coordinating and publishing submission documents.
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and background documents for Regulatory Authority meetings.
- Work with partners in Europe and Asia to prepare applications, respond to queries to enable maintenance of CMC needs for clinical activities outside of the United States.
- Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues.
- Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders.
- Assure compliance with regulatory standards and guidance documents.
- Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements.
- Conduct risk assessments of global CMC regulatory issues.
- Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence that motivates employees to perform at their highest ability.
- Reward and recognize employees and teams who take initiative beyond expectations to advance business goals.
Qualifications
- Bachelors degree in a scientific discipline required. Advanced degree (MS, PhD, PharmD) preferred.
- 12+ years of Regulatory CMC experience in the Biotech/Pharmaceutical industry.
- Demonstrated knowledge of small molecule Chemistry, Manufacturing and Controls and Quality Assurance.
- Proven experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
- Global regulatory experience highly desired. Experience with labeling requirements is a plus.
- Demonstrated management expertise, including leadership and development of Regulatory employees.
- Excellent listening, verbal and written communication and presentation skills, as this position will interface with all levels within the organization, regulators, partners and key opinion leaders.
- Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Skilled in working in a fast-paced environment managing multiple competing tasks and demands combined with hands-on attention to detail with the ability to step back and think holistically.
- Strategic thinker, planner, and implementer with a proven track record practicing sound and timely judgment.
- Ability to examine and understand issues from multiple perspectives or points of view in a matrix environment.
- Strong team leadership skills with the ability to foster high-performing teams (both functionally and cross-functionally).
- Ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and discipline.