Company Summary:
Located in San Diego, CA, Shoreline Biosciences, Inc. is focused on changing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Shoreline was recognized by the California Life Sciences as the Pantheon 2021 award winner for the Strategic Partnership of the Year Award. Join our winning team.
Position Summary:
Shoreline Biosciences is seeking an experienced and talented Senior Director of Regulatory Affairs. This key position plays a pivotal role in overseeing and directing regulatory strategies and activities related to the development and approval of cell therapy products within the Shorelines portfolio. The Senior Director will coordinate and oversee regulatory activities across functions in the organization and will be responsib le for ensuring compliance with requirements and guidelines set forth by global regulatory agencies while providing strategic leadership to support organizational goals. This will be a full-time position reporting directly to the Chief Medical Officer. The anticipated salary range for this position is $1 90,000 to $307,000. The final salary offered to a successful candidate is dependent on the candidate's experience, qualifications, geographic location, and other job-related factors. In addition to base salary, the hired candidate is eligible to receive an annual bonus and will receive an equity grant at the time of hire in the form of the option to purchase stock in the future for a specified price.
Primary Responsibilities:
- Provide strategic leadership and oversight of clinical regulatory strategy, agency interactions, and submissions.
- Interact with the Executive team to help define the Regulatory Strategy for both internal and partnership programs.
- Lead the compilation, review, and submission of regulatory interactions with agencies, including pre-submission meetings, IND/CTA submission and regulatory authority inquiries, ensuring completeness, accuracy, and timeliness.
- Provide oversight and support around Regulatory CMC strategy.
- Support development teams and provide direction on the interpretation and application of regulations and guidance documents.
- Provide strategic and regulatory compliance input to protocols, reports, and other source documents.
- Maintain current knowledge of global regulatory guidance, regulations, and competitive intelligence; communicate key updates to senior leadership and project teams as appropriate; develop and implement new processes as necessary to achieve regulatory compliance.
- Lead regulatory meetings with agencies; develop briefing packages for meetings with FDA and other regulatory agencies.
- Work with the cross-functional teams and support functions including full time staff and independent consultants, as needed.
Qualifications:
Education & Experience
- 10+ years of Clinical Regulatory Affairs experience in drug development.
- Advanced degree in a scientific discipline is required.
- Direct and significant hands-on regulatory experience leading Clinical, Nonclinical, and CMC strategy and documentation for pre-submission meetings, INDs/CTAs, and BLA/MAAs .
- Proven experience developing regulatory submissions in the biotechnology space, preferentially in the cell therapy space.
Skills & Knowledge
- Strong knowledge of FDA and EMA regulations required.
- Experience with mechanisms to facilitate and expedite agency interactions, including Fast-Track, Breakthrough Designation.
- Experience in leading Health Authority meetings.
- Excellent communication skills with the ability to influence across all functions and levels within the organization and with external stakeholders.
- Self-motivated, self-disciplined, and able to function independently as well as part of a team.
- Strategic agility, strong critical and logical thinking with ability to analyze and creatively solve challenging problems.
- Strong organizational skills with the ability to prioritize, multi-task, and work in an evolving and fast-paced environment
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
- The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- This position requires the ability to occasionally lift and/or move up to 10 pounds.
Work Environment:
- Work in and around common laboratory equipment.
- The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment.
- 100% on-site work at corporate headquarters in San Diego, CA.
- Evening and weekend work as necessary.
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.