- Liaise with internal teams and external partners in order to execute program team objectives. This includes the evaluation of CMC regulatory risks/gaps and developing contingency plans with a focus on efficient global planning for first in human and proof of concept (POC) studies.
- Work with CMC quality teams to generate phase-appropriate standards for work and regulatory dossiers.
- Identify and manage CMC risks for programs in a phase-appropriate manner.
- Author and review responses to regulatory questions and manage impact of regulatory feedback in updates to submissions and activities to be carried out by CMC.
- Develop of a network of consultants and other external resources to help with the regulatory CMC workload from specialize advice to core activities.
- Bachelors or higher in pharmaceutical sciences or related field required
- Experience (5-10 years) in the biopharma industry, particularly in late preclinical stage and in phase 1 and 2 clinical trials, in a CMC Regulatory Affairs role and proven ability to represent CMC Regulatory Affairs on project teams and to Health Authorities
- Demonstrated leadership and track record of regulatory submissions, including effective project management
- Excellent communication and organizational skills
- Strong attention to detail and process oriented
- Strong time management skills; ability to prioritize multiple tasks efficiently
- Resourceful and flexible: manage multiple and changing priorities in a dynamic environment
- Ability to think creatively and independently, and to proactively manage regulatory risk
- Ability to collaborate with teams to achieve goals and objectives.
- Track record of providing scientifically informed regulatory advice which includes strategic options and associated risks.
- Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals.