Haystack Oncology is a precision medicine company based on over two decades of technology and clinical development in the field of liquid biopsy. The mission of Haystack Oncology is to develop and deliver to the clinic a best-in-class personalized cancer diagnostic to identify the maximal number of patients with residual, recurrent, and resistant disease that stand to benefit from proactive clinical interventions. Haystack Oncology's best-in-class MRD test delivers more sensitive earlier detection of lurking disease leading to better chances for cure and aims to benefit all patients with solid tumors.
The Senior Manager, Regulatory Affairs (RA) will be an instrumental member of the Regulatory Affairs team supporting IVD product development teams, U.S. and international submissions and technical documentation, change management, and regulatory compliance. The incumbent is responsible for supporting compliance with FDA, CLIA, CAP, CLEP/NY, IVDR, and other global regulatory requirements.
The Senior Manager, Regulatory Affairs will interact with various functions and provide regulatory guidance as needed. The Senior Manager, Regulatory Affairs will have strong diagnostic industry experience and demonstrated proficiency in interpreting regulatory guidelines in the specific context of high complexity molecular testing plays, an essential role throughout all stages of product development and commercialization.
Responsibilities
- Represents the RA function on assigned cross-functional project teams.
- Interprets and applies regulations by creating regulatory strategies.
- Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations.
- Prepares hardcopy and electronic information packages for submission to regulatory agencies.
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
- Reviews validation, clinical and stability protocols, and reports for regulatory submission soundness.
- Reviews incoming project contracts and provide guidance for regulatory requirements for projects.
- Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations.
- Monitors new and revised regulatory requirements; disseminates information as directed by management.
- Interacts with regulatory agencies and third-party accrediting bodies.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with relevant stakeholders to ensure compliance with local regulations.
- Stays current on new regulatory or other industry initiatives that could have a significant impact on the company’s current or development products.
- Prepares internal procedures for continuous process improvement.
- Mentors and hires junior members of the department.
- Provides regulatory guidance and/or training to external departments and partners.
- Assists with resource planning and budgeting as needed
Required Education and Experience
- BS degree in Chemistry, Biology, or other relevant discipline; work experience may substitute.
- Experience with an in vitro diagnostics device multi-nation company required; pharmaceutical, biologics or medical device companies as alternative.
- Strong understanding of FDA regulations required; other international requirements - EU, Canada, Australia, Japan - preferred.
- Strong experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements.
- Proven hands-on experience in submission and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Strong written and verbal communication skills
Preferred Skills, Qualifications, or Technical Proficiencies
- Requires Bachelor's degree or equivalent with 10+ years of direct work experience.
- Additional coursework in regulatory or quality strongly desired.
- Managers at this level may become involved in day-to-day activities where their acquired expertise and knowledge provide focus to subordinates.
- Uses interpersonal skills to influence customers, suppliers, and other comparable level managers.
Haystack Oncology is an equal opportunity employer. We thrive on diversity and collaboration.