Manager/Sr. Manager, Regulatory Affairs

Redwood Shores, CA 94065

Posted: 10/13/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 18037

Job Description


Telios Pharma, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing therapeutics to improve lives of patients with cancer. Launched in 2019 by proven industry veterans, we are a passionate team based in Redwood City, California and Bellevue, Washington. We have brought together scientists and clinicians with a deep understanding of hematology and oncology and an experienced leadership team. Together, we’ re building an exciting biotechnology company with a culture defined by caring, ambition, dedication and teamwork!

Job Summary:

Under the leadership of the VP of Regulatory Affairs, the Manager/Sr. Manager,  Regulatory Affairs will assist in building a high performing global regulatory function for Telios Pharma, Inc. 

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
  • 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
  • Excellent 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
  • Excellent 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

Qualifications:
  • Bachelors Degree required (life sciences disciplines strongly preferred) 
  • Average of 8 or more 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 and globally 
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat

Meet Your Recruiter

Ashley Lee

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