Director, Regulatory Affairs CMC

The Director, Regulatory Affairs CMC at Olema Oncology is responsible for developing and executing CMC regulatory strategies for products in development and post-approval. This includes ensuring compliance with global Health Authority requirements, managing regulatory interactions, overseeing the development of CMC sections for regulatory submissions, and providing strategic regulatory guidance to cross-functional teams.

To qualify for the Director, Regulatory Affairs CMC role at Olema Oncology, candidates should have a Bachelor's degree in a scientific field, with an advanced degree being a plus. Additionally, at least 10 years of experience in clinical research or biotech, along with 8 years in Regulatory Affairs, is required. Familiarity with CMC regulations and experience in small molecule drug development are also essential.

As the Director, Regulatory Affairs CMC at Olema Oncology, you will play a key role in compiling, reviewing, and submitting high-quality CMC sections of regulatory submissions. This includes responding to queries from regulatory authorities and collaborating with teams in Research, Manufacturing, and Quality Assurance to ensure that all submissions meet regulatory standards.

Olema Oncology prefers candidates for the Director, Regulatory Affairs CMC position to have significant experience in clinical research, biotech, or pharmaceuticals, particularly with at least 8 years in Regulatory Affairs. Global CMC regulatory experience for clinical trials is essential, along with a solid understanding of FDA/EMA regulations.

The work environment for the Director, Regulatory Affairs CMC at Olema Oncology is collaborative and dynamic. You will be part of a dedicated team striving to create impactful therapies while fostering open communication and cross-functional collaboration. The role requires adaptability within an evolving industry and promotes a culture of learning and professional growth.

In your response, highlight specific experiences where you successfully navigated CMC regulations in your previous roles. Discuss your familiarity with FDA and EMA guidelines, and how you've ensured compliance in regulatory submissions.

Discuss your approach to project management, emphasizing leadership, communication, and collaboration with cross-functional teams to meet deadlines without compromising quality. Showcase your ability to prioritize tasks effectively.

Mention the resources you use, such as regulatory publications, industry webinars, and professional network groups. Illustrate your commitment to continuous learning and adapting to the regulatory environment.

Provide a clear example, detailing the challenge, your analysis, and the steps you took to address it. Focus on the outcome and lessons learned to demonstrate your problem-solving skills.

Share details of specific projects that involved international submissions, focusing on the complexities you faced and how you managed compliance across different jurisdictions.

Discuss your communication style and approach to building relationships across departments. Provide examples of how you've fostered teamwork to ensure alignment on regulatory strategies.

Explain the importance of change control in regulatory compliance and detail your strategies for managing changes within your teams in previous roles, ensuring transparency and adherence to regulations.

Discuss specific instances where you have handled electronic submissions under eCTD requirements, highlighting your understanding of the format and any successful outcomes from those submissions.

Illustrate your experience providing guidance during various phases of clinical trials, emphasizing collaboration with clinical teams and your ability to proactively identify and mitigate regulatory risks.

Detail your strategies for training teams on GXP compliance, conducting audits, and implementing best practices, showcasing your commitment to maintaining high compliance standards.