Lead, Regulatory Affairs CMC

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

The CMC Regulatory Lead (Director/Sr. Director level) will be responsible for developing and executing innovative regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) development for our early to late stage development pipeline products within Regulatory Affairs. The successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the CMC/Quality leadership to achieve development milestones in an efficient and compliant manner. The role requires a strong scientific background with understanding and experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines.

The successful candidate will interface cross-functionally in a matrixed environment to integrate CMC plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions (e.g., BLA) to meet overall program objectives/milestones.

• Manage all aspects of CMC regulatory strategy development for Orca Bio products (early- to late-stage/registration/post-market).
• Lead authoring of meeting package information for regulatory CMC interactions in the US and globally.
• Oversee content development and authoring of Mod 3 and lead authoring of Mod 2.3 for BLA/MAA filings.
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance.
• Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks.
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on the Orca Bio development programs and understand the regulatory landscape.
• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation.
• Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals.
• Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons.
• Lead CMC regulatory submission development - Responsible for planning, coordinating, developing and authoring high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).

• Bachelor’s degree (or equivalent) in life sciences, masters or advanced degree with strong scientific acumen; PhD preferred.
• Prior regulatory filing (BLA) experience with cell or gene therapies preferred.
• 10+ years working within the biotech/pharmaceutical industry, preferably at a small company.
• 8+ years of pharma and/or biotech regulatory CMC-experience.
• In-depth Knowledge of cGMP, CMC regulatory requirements, domestic and globally.
• Ability to lead matrixed teams, drive and influence effective collaborations, with a hands-on mindset.
• Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
• Initiative-taking, self-disciplined, and able to function independently as well as part of a team, with a practical and flexible mindset.
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.

The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

To learn more: https://orcabio.com/join-our-team/

**all official communication will be from @orcabio.com; please beware of scams**

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.