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Director Regulatory Affairs

Employer
Aspen Neuroscience
Location
San Diego, California
Start date
Nov 12, 2021

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
NextGen Bio

Job Details

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. 

Company

Headquartered in San Diego, Aspen Neuroscience, Inc. is a development stage, private biotechnology company focused on personalized cell therapies. We are developing autologous (the patient’s own) induced-pluripotent stem cells (iPSCs) to address diseases with high unmet medical need, beginning with autologous neuron replacement for both sporadic and genetic forms of Parkinson’s disease (PD).

As a leading iPSC platform company, we combine stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. We have developed a best-in-class platform to create and characterize pluripotent-derived cell medicines, including in-house bioinformatics, manufacturing and QC.

Located in scenic Torrey Pines, Aspen features a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and collaboration. The leadership team is committed to attracting and retaining the highest caliber talent to develop meaningful therapies for patients in need.

aspen

 

Company info
Website
Phone
(858) 263-1222
Location
10835 Road to the Cure, Ste. 100
San Diego
California
92121
United States

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