Director, CMC Regulatory Affairs
Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader wiling to contribute to overall regulatory strategy. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.
- Oversees, coordinates and delivers on CMC regulatory submissions and other relevant regulatory documentation
- Responsible to ensure all CMC RA deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
- Provides regulatory CMC expertise and is able to develop sound regulatory strategies and leadership to cross-functional teams and other groups
- Serves as the primary CMC RA representative on one or more projects at any one point in time
- Analyzes data, the regulatory environment and business objectives to recommend priorities
- Provides internal teams with direction on regulatory authority interactions
- Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
- Participates as a standing member in various teams, dependent upon assigned projects and the associated programs, coordinates cross-functional contributions
- Member of the Regulatory leadership team
- Responsible for coordinating and facilitating CMC Health Authority Interactions
- Outstanding attention-to-detail
- Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
- Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
- Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
- Outstanding written communication skills
- Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
- Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
- Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
- Works well within teams and is effective in collaborating with others internally and externally
- Bachelors Degree required (life sciences disciplines strongly preferred)
- Average of 10 or more years’ relevant experience in CMC regulatory affairs or related functions in drug development/manufacturing
- Broad understanding of international regulations, processes and issues in drug development.
- Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
Principia Biopharma, Inc. is an equal opportunity employer.