Working at the interface of computation, engineering, and biology, AbCellera is redefining how drugs are discovered. We’ve developed an AI-powered technology stack to discover antibodies and deliver large pools of curated candidates to our partners. And, we’re not stopping there. We’re expanding our capabilities to include early development, from candidate selection through to IND and potentially further. We aim to bring therapies from idea to patients, faster.
We are seeking a Director of Regulatory Affairs who will manage worldwide interactions and negotiations with regulatory agencies and partners in support of pre-clinical regulatory activities through Phase 1 studies. You will be a key member of project teams and teams responsible for evaluation of product concepts. Reporting to the Senior Director, Early Development - Oncology you will be responsible for ensuring the regulatory strategy is aligned with health authority requirements and regulatory submissions are on time and of high quality.
How you might spend your days:
- Leading program teams in preparing regulatory submissions including briefing documents, IND and CTA filings
- Overseeing preparation of responses to all regulatory authority queries
- Planning and leading meetings with regulatory authorities
- Managing critical clinical regulatory timelines, working with team members to resolve issues related to non-clinical studies, and clinical development, and working in partnership with the CMC team.
- Serving as the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for all clinical related issues
- Maintaining detailed knowledge of global regulatory environment relevant for biologics including accelerated review programs. Communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
- Collaborating with external consultants, clinicians, CROs to provide regulatory guidance
- Evaluating regulatory program risks and establish mitigation strategies pertinent to clinical development.
- Partnering with CMC, Discovery, and Clinical Development organizations to innovate strategies to accelerate submission timeline
- Escalating issues to Management that affect regulatory compliance
We’d love to hear from you if:
- You have a strong knowledge of eCTD elements and structure, and regulatory writing skills
- You have demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
- You can manage contract staff and vendors as needed to support regulatory activities
- You have exceptional interpersonal skills that promote a collaborative and productive lab environment
- You have effective and efficient written and oral communication skills
- You are able and excited to work in a fast-paced environment, handling multiple responsibilities simultaneously
- You have strong attention to detail and excellent organizational skills with an ability to prioritize effectively to deliver results within reasonably established timelines
- You work effectively both independently and as part of a team
Required qualifications and experience:
- A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required
- 7-10 years of experience inclusive of postgraduate education and/or Advanced scientific degree preferred in the sciences, or health related field
- Knowledge of EMA and FDA regulations is required. Experience in filing regulatory submissions required
- Experience in biologics is preferred
- Experience directly writing submission documents is preferred
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we create innovative solutions for our partners - combining custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We’re looking for someone like you to support, organize and innovate on our efforts along the way.