Director/Sr. Director, Regulatory Affairs CMC
Regulatory Affairs – Regulatory Affairs /
Regular, Full-Time Employee
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
This position will be responsible for developing and executing innovative regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) development for our early development pipeline products within the Regulatory Affairs department. In this lead, direct role, 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 would require a strong scientific background with understanding and experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines to contribute to and shape the overall manufacturing strategy.
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 to meet overall program objectives/milestones.
- Lead and 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 global 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.).
- Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
- Bachelor’s degree (or equivalent) in life sciences, masters or advanced degree preferred.
- Prior regulatory filing (BLA/MAA) experience with cell or gene therapies
- 10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
- In-depth Knowledge of cGMP, CMC regulatory requirements in domestic and globally.
- Ability to lead matrixed teams, drive and influence effective collaborations.
- 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.
- Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
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 patients who need them.
We strive to do things right. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not”, and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
We invite you to join us and bring your unique perspective and experiences to our team.