Job description
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.
Reporting to the Head of Regulatory Affairs, the Associate Director is responsible for the development and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company’s policies, and support business objectives. The individual is also responsible for leading and/or contributing to the planning, coordination, and execution of other post approval regulatory submissions.
The successful candidate will interface cross-functionally in a matrixed environment to integrate commercial Regulatory plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
Some travel required, as needed.
Key Responsibilities
- Responsibility for defining commercial regulatory strategies, ensuring that all corporate communications are compliant with regulatory standards.
- Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
- Reviews and approves all US promotional materials working closely with cross-functional teams to ensure compliance with regulatory requirements and alignment with U.S. promotional regulations, corporate standards and policies and business objectives.
- Management of the strategy and operational aspects of regulatory labeling for Phase 3 and commercial assets, ensuring that all labeling is accurate, compliant, and effectively communicates the necessary information to healthcare professionals and patients.
- Serve as the liaison and manage correspondence with FDA’s promotional review divisions and provide input on application labeling negotiations.
- Additionally, leading the strategy, coordination and execution of post approval regulatory submissions (e.g., phase 3b/4 studies, amendments, aggregate annual reporting etc.)., ensuring that all submissions are timely and meet the expectations of regulatory agencies.
- Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
- Lead the development of Regulatory Affairs SOPs relevant to commercial procedures.
- Represents RA Commercial at Regulatory team meetings as well as to stakeholders and cross-functional team members.
Qualifications
- Master’s degree or other advanced degree in life sciences, 10+ years working within the biotech/pharmaceutical industry, and 5+ years of Regulatory Ad/Promo experience required
- Prior regulatory filing (BLA/MAA) experience with cell or gene therapies preferred
- Experience managing commercial regulatory strategy and labeling function required
- Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
- 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.
- Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus
- 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 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.
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.
