The Regulatory CMC Manager will be responsible for authoring and preparing regulatory packages in support of the chemistry, manufacturing, and controls (CMC) development for our early- to late-stage development pipeline products. The successful candidate will support the development and execution of regulatory strategies within Regulatory Affairs, working closely with CMC and Quality teams to ensure alignment with development milestones and regulatory compliance. This role requires a strong scientific background with experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines.The successful candidate will work cross-functionally in a matrixed environment to integrate CMC plans with overall development plans, ensuring the preparation of timely and high-quality regulatory submissions (e.g., BLA) to meet program objectives.
Responsibilities
- Lead the authoring and preparation of meeting packages for regulatory CMC interactions in the US and globally.
- Develop and review content for Mod 3 and assist with Mod 2.3 for BLA/MAA filings.
- Support the development of CMC regulatory strategies for Orca Bio products (early- to late-stage/registration/post-market).
- Work with cross-functional teams to ensure regulatory packages align with overall development objectives and timelines.
- Identify and communicate regulatory risks, supporting the development of strategies to mitigate risks.
- Monitor regulatory agency activities related to CMC development and assess potential impacts on Orca Bio programs.
- Assist in evaluating proposed manufacturing changes for global impact and contribute to strategic regulatory strategies.
- Participate as a CMC Regulatory representative on cross-functional project teams to support project milestones.
- Serve as a regulatory contact for Contract Manufacturing Organizations (CMOs) and support interactions with Qualified Persons.
- Support the planning, coordination, and development of CMC (Quality) regulatory submissions, ensuring compliance with current regulatory requirements and guidance.
Qualifications
- Bachelor’s degree (or equivalent) in life sciences; advanced degree preferred.
- 5+ years of experience in the biotech/pharmaceutical industry.
- 4+ years of experience in CMC regulatory affairs within pharma or biotech, preferably within cell therapies.
- Knowledge of cGMP, CMC regulatory requirements, both domestic and global.
- Strong scientific writing skills, with an emphasis on preparing high-quality regulatory packages (BLA/late stage submissions preferred).
- Ability to work effectively in cross-functional teams with a collaborative and hands-on approach.
- Initiative-taking and able to manage multiple tasks independently.
- Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
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.
United States
