Director/Senior Director, Regulatory CMC

Gh Gruppe; South San Francisco (CA); On-site; USD 159,000 - 286,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Director/Senior Director of Regulatory CMC to lead regulatory activities for its therapeutic pipeline. This pivotal role involves developing and executing regulatory strategies, ensuring compliance with global standards, and collaborating with cross-functional teams to achieve successful drug approvals. The ideal candidate will have extensive experience in regulatory affairs, particularly in CMC, and a strong understanding of drug development processes. Join a forward-thinking organization that values strategic leadership and offers a competitive rewards package, including base salary, bonuses, and health benefits.

Benefits

Annual performance bonus

Company equity

Generous health benefits

Qualifications

• 12+ years in regulatory affairs, with 7+ years in regulatory CMC.
• Proven experience in regulatory submissions and health authority interactions.

Responsibilities

• Lead regulatory strategies for CMC-related submissions.
• Ensure compliance with global regulatory requirements.

Skills

Global CMC regulatory requirements

Drug development processes

Excellent communication skills

Project management skills

Regulatory submission management tools

Education

MS in Life Sciences

Equivalent degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Electronic submission systems

Job description

Director/Senior Director, Regulatory CMC

About BridgeBio Oncology Therapeutics

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio Services, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors.

The Director/Senior Director of Regulatory CMC will be responsible for leading regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) to support the progression of our therapeutic pipeline. This role requires a deep expertise in global regulatory requirements and provides strategic leadership across all stages of drug development. The position will directly report to the Senior Vice President (SVP) of Chemistry, Manufacturing, and Controls (CMC) and work closely with cross-functional teams to ensure successful regulatory approval of drug products and provide guidance on regulatory strategy.

Key Responsibilities:

• Lead the development and execution of regulatory strategies for CMC-related submissions in support of clinical trials, marketing applications, and product lifecycle management.
• Develop, review, and ensure timely submission of regulatory filings to global regulatory authorities.
• Provide regulatory expertise on CMC issues, anticipating regulatory concerns, and proposing innovative solutions.
• Work closely with cross-functional teams (e.g., Research & Development, Manufacturing, Quality, Clinical, and Project Management) to ensure CMC regulatory strategy aligns with overall program objectives and timelines.

Regulatory Compliance & Guidance:

• Serve as the regulatory lead for CMC-related issues, ensuring compliance with applicable global regulatory requirements (FDA, EMA, ICH guidelines, etc.).
• Lead regulatory interactions with global health authorities, including preparing for and participating in meetings, responding to questions, and negotiating with regulatory agencies.
• Stay abreast of regulatory trends, guidance documents, and changes to global regulatory requirements affecting CMC.

Leadership and Collaboration:

• Collaborate with senior leadership to provide regulatory input into product development strategies and timelines.
• Engage with external partners (e.g., CMOs, CROs) as needed to ensure alignment with regulatory expectations.

Risk Management and Decision Making:

• Identify, assess, and mitigate regulatory risks related to CMC activities and product development timelines.
• Provide sound, data-driven regulatory advice to cross-functional teams to ensure strategic decisions are made in compliance with regulatory expectations.

Documentation and Reporting:

• Ensure the preparation, review, and submission of high-quality regulatory documentation for CMC-related filings.
• Maintain accurate records of regulatory correspondence and filing history, tracking submission progress and responding to agency inquiries in a timely manner.

Education, Experience & Skills Requirements

Education:

• MS, or equivalent degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Experience:

• Minimum 12+ years of experience in regulatory affairs, with at least 7 years specifically in regulatory CMC within the biotech or pharmaceutical industry.
• Proven experience in regulatory submissions and successful interactions with health authorities.
• Experience leading a team and mentoring junior staff.

Skills:

• Expertise in global CMC regulatory requirements and best practices.
• Strong understanding of drug development processes (FDA/EMA/ICH) from early-stage clinical development through commercialization.
• Excellent communication skills, both written and oral, with the ability to present complex regulatory data and strategies to senior management and regulatory agencies.
• Strong project management skills, with the ability to manage multiple priorities and meet deadlines.
• Proficiency in the use of regulatory submission management tools and electronic submission systems.

Personal Attributes:

• Results-oriented with the ability to navigate complex regulatory challenges.
• Collaborative leader with the ability to influence decision-making across a matrix organization.
• Ability to work efficiently and make swift decisions in a fast-paced environment, adapting quickly to new challenges and priorities.
• Strategic thinker with a proactive approach to identifying opportunities and risks.
• Detail-oriented with a commitment to ensuring compliance and quality in regulatory submissions.

Additional Information:

• Occasional travel to support global regulatory interactions and meetings as required.

At BridgeBio Oncology Therapeutics (BBOT), we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.

Salary Range: $159,000 - $286,000 USD

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