CMC Technical Writer
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.
The Senior Manager, CMC Technical Writer will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
- Author and/or review technical reports as required by CMC functional leaders.
- Author, compile, and manage CMC sections of a wide variety of regulatory submissions including, but not limited to, CMC Information Amendments, regulatory responses to CMC IRs, QOS, briefing book meeting packages and BLA/MAA etc.
- Effectively manage the integrated drafting and reviewing process following aggressive filing timeline.
- Collaborate effectively with CMC SMEs to prepare CMC sections of the regulatory dossiers including IND, CMC Information Amendments, briefing documents, regulatory responses and BLA.
- Critically review and maintain the source documents for consistency, completeness, and quality.
- Minimum Bachelor's degree (M.S. or Ph.D. preferred) in Chemical, and/or, Biological Sciences/relevant discipline.
- 5+ years' experience in CMC regulatory filing experience is required.
- Must have strong working knowledge of full spectrum of CMC including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general.
- CMC experience with cell-based therapies strongly preferred.
- Strong technical writing skill is required.
- Prior experience in the preparation of CMC sections of regulatory dossiers in eCTD format is required, prior BLA filing experience is strongly preferred.
- Prior working experience with regulatory document formatting and eCTD viewer is strongly preferred.
- Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure.
- Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities.
- Working in a cross functional team environment.
- Excellent verbal/written communication skills.
- Proven planning and organizational skills and regulatory writing skills.
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage. multiple competing tasks and demands.
- Detail/accuracy oriented.
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.