Job Summary:
Scorpion Therapeutics is seeking a highly experienced and motivated Director/Sr. Director of Regulatory Affairs-CMC (Chemistry, Manufacturing, and Controls) to lead the development and execution of regulatory strategies for the company’s CMC activities. This role is crucial in ensuring that all CMC aspects of drug development meet regulatory requirements globally, supporting Scorpion Therapeutics' mission to bring transformative oncology therapies to patients.
The Director/Sr. Director, Regulatory Affairs-CMC will work closely with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, and Clinical Development, to ensure the successful submission of CMC dossiers and compliance with regulatory guidelines across regions (US, EU, APEC) throughout the product lifecycle.
Key Responsibilities:
- Lead the development of global regulatory CMC strategies for solid dosage forms, ensuring alignment with overall product development plans and company goals.
- Oversee the preparation, review, and submission of high-quality CMC sections of regulatory filings, including INDs, NDAs, BLAs, and other global regulatory submissions including query responses. Ensure all documentation meets regulatory standards and is submitted within timelines.
- Ensure CMC activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.). Identify potential regulatory risks related to CMC and develop strategies to mitigate these risks.
- Serve as the primary CMC regulatory contact with regulatory authorities. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
- Lead and mentor a team of regulatory professionals, fostering a collaborative and high-performance work environment. Provide strategic direction and professional development support to team members.
- Collaborate with R&D, Quality, Manufacturing, and other departments to ensure CMC regulatory strategies are integrated into overall product development plans. Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle.
- Monitor and interpret evolving regulatory guidelines and trends, ensuring the company's CMC strategies remain current and compliant with global standards. Provide regulatory insights and recommendations to senior leadership.
- Lead CMC regulatory projects, ensuring all deliverables are met on time and within scope. Manage relationships with external partners and vendors involved in regulatory CMC activities.
Qualifications:
- Advanced degree (Ph.D., Pharm.D., or equivalent) in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering).
- Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Experience in solid dosage form with oncology products is highly desirable.
- Develops organizational procedures and processes and leads implementation. Provides direction and share expertise with various functional areas as appropriate.
- In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc.). Proven track record of successful CMC submissions for INDs, NDAs, BLAs, and other regulatory filings.
- Demonstrated ability to lead and develop high-performing teams. Strong strategic thinking, decision-making, and problem-solving skills.
- Excellent written and verbal communication skills. Ability to effectively communicate complex technical information to regulatory authorities, senior management, and cross-functional teams.
- Strong project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.
- Ability to thrive in a fast-paced, dynamic environment and manage changing priorities.
Compensation:
The salary band for this role will be between $225,000-$240,000. Additional to the base salary, we offer an annual target bonus and equity ownership in the company.