Director Regulatory Affairs

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Job description

Aspen Therapeutics is seeking a Director of Regulatory Affairs to help lead the establishment and execution of regulatory strategies and submissions process for our cutting edge autologous stem cell-based therapy for Parkinson's disease. This new role requires exceptional leadership skills and proven regulatory expertise. The ideal candidate is eager to be part of building a unique and vibrant culture of collaboration in a fast-paced environment that recognizes both individual and collective success.

Responsibilities:

• Responsible to ensure all RA deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
• Responsible for development and execution of regulatory strategies for the each project
• 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

  Education & Experience:

• Bachelor's Degree required (life sciences disciplines strongly preferred)
• 10+ years' relevant experience in regulatory affairs or related functions in drug or biologics development.
• Cell and Gene therapy experience preferred
• 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

• Job Specifications:

• Outstanding attention to detail
• Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
• 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

​EEO and Employment Eligibility

• Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.
  

  Total Rewards and Culture

  Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.