Associate Director, Regulatory Affairs

Job Description:

Our Associate Director, Regulatory Affairs will be responsible for ensuring all RA deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines. This person:

• Oversees, coordinates and delivers on regulatory submissions and other relevant regulatory documentation
• Provides regulatory expertise and leadership to cross-functional teams and other groups
• Serves as the primary RA representative on one or more global 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

Abilities:

• 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

Minimum Qualifications:

• Bachelors Degree required (life sciences disciplines strongly preferred)

• 7+years' relevant experience in regulatory affairs or related functions in drug/biologics development
• Broad understanding of international regulations, processes and issues in drug/biologics 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 is an equal opportunity employer.