Associate Regulatory Program Director
Roche, South San Francisco, United States
Closing Date for Applications:
In this role, you will be:
- Accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
- Accountable for submissions of high quality CMC regulatory documents to health authorities in accordance with Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
- Effective management of regulatory changes throughout the product life cycle.
- Coordinating and/or leading health authority interactions for assigned projects; representing Technical Regulatory at multidisciplinary meetings with health authorities.
- Representation of PT on other cross-functional teams, such as Technical Development Teams (TDTs) and Regulatory Affairs Functional Teams (RAFTs).
- Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
- If applicable, leading a Technical Regulatory Team (TRT) or one or several technical regulatory professionals (depending on complexity of the program).
- Accountable to keep abreast of regulatory procedures and changes.
- Recommends strategies for earliest possible approvals of clinical trial applications.
- Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- Bachelor’s degree required- preferably in a scientific field; an advanced degree is a plus.
- A minimum of 5 - 10 years of work experience in the pharmaceutical, biotechnology or related industry, CMC, quality, regulatory or related experience.
- A regulatory professional with a depth of experience and knowledge and the ability to manage complex issues with efficiency.
- Experience in CMC regulatory consideration for small molecules is preferred; other modalities including biologics, device/combination products are an advantage.
- You should bring experience in technical (CMC) development.
- Strong leader who is an agile strategic thinker with exceptional communication skills.
- Possesses the ability to prioritize and work effectively both within a team environment and independently.
- Ability to influence teams and functions in defining global technical regulatory strategies.
- You are comfortable with taking risks, experimentation and ambiguity.
- You take ownership, are decisive, and use your knowledge, network and creativity to solve problems and progress programs and projects.