Sandra J Hecker
Senior Regulatory Strategist and Liaison with FDA for small molecule and biologic products; US Agent
- Role
- Regulatory Strategist, Us Agent, Regulatory Research Analyst at Hecker & Associates, Llc
- Location
- Arlington, VA, US
- LinkedIn followers
- 500 followers
About Sandra J Hecker
Extensive experience supporting/coaching small molecule and biologic product development…
Experience
Regulatory Strategist, Us Agent, Regulatory Research Analyst
Jul 2001 — Present
I recommend and lead regulatory strategy for biologic and small molecule projects to achieve a client\'s global clinical trial and marketing application goals. Since 2018, I\'ve focus on coaching small, novice US and foreign companies working on oncology INDs, resulting in successful Pre-IND meetings and INDs that were allowed to proceed. As US Agent, I represent foreign (Asian, European, UK) companies to FDA to ensure best application of their earlier product development data from elsewhere in the world in their IND. I coach teams about how best to work with FDA to achieve clinical trial and marketing application goals, and for global submissions, the importance of aligning and prioritizing goals across regions, for the benefit of patients.As a contractor, I can choose my clients, But sometimes, big pharma corporate management requires that I be replaced with an employee, which happened in Feb 2022. That corporate decision was disappointing. That contract included a gene therapy project as well as a rare disease project that was the most complicated project I\'ve ever supported that David (at the time, a Takeda VP) mentions below. I so appreciated the team\'s support and team leadership\'s efforts to keep me as a global regulatory lead contractor at Takeda, even if unsuccessful.
Education
Amherst College
BA cum laude
Hartford College for Women
AA
Skills
- Clinical Trials
- Clinical Development
- Neuroscience
- Technology Transfer
- CRO
- Regulatory Affairs
- Clinical Research
- Document Management
- Ind
- Immunology
- Protocol Development
- Diabetes
- Drug Development
- Gcp
- Biopharmaceuticals
- Cardiology
- Infectious Diseases
- Project Management
- Strategic Planning
- Medical Writing
- U.s. Food and Drug Administration (Fda)
- Nda
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Fda
- Neurology
- Standard Operating Procedure (Sop)
- Oncology
- Protocol
- Clinical
- Biotechnology
- Good Clinical Practice (Gcp)
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