Driven Vice President, Regulatory Affairs - New York, United States - Grnwestpalmbeach
Description
** Driven Vice President, Regulatory Affairs & Quality Assurance-NYNY**
**Required Experience:**
Leads/participates in development and execution of regulatory strategy
Interacts with regulatory agencies
**Required Education:**
BA/BS (or equivalent) in pharmacy, chemistry, biology, or a related science
10+ years of relevant Regulatory Affairs experience (RA)
Eric Dolgenas
Phone:
Email:
Ref Id:DBE9-3227 **Job Description**
A worldwide pioneer in molecular diagnostics with leading life sciences products, intellectual property and emerging clinical laboratory testing products and services that is developing of unique diagnostic platform technologies is seeking a Vice President, Regulatory Affairs & Quality Assurance for its NY location. The company utilizes cross-functional teams to develop and deploy products systems and services that meet the ever-changing and rapidly growing healthcare needs and provide numerous advantages over previous standards
The Vice President of Regulatory Affairs and Quality Assurance, as a subject matter expert, will lead our regulatory affairs and quality team. In this role, you will oversee and direct regulatory and quality activities for new and mature products to ensure alignment and compliance with local, regional, and global registration requirements, as well as, with company policies. You will partner with the global operations team to develop, submit and deliver products with proper regulatory approval.
**Knowledge & Skills**
Key Duties, Activities and Responsibilities:
Leads/participates in development and execution of regulatory strategy for projects
Interacts with regulatory agencies
Manages regulatory submission activities from development through approval to market and subsequent life-cycle changes
Writes, edits, and reviews various regulatory reports and documentation to ensure regulatory compliance for submission to INDs, NDAs, and other applications, utilizing best practices in life cycle management of regulatory documents
Leads cross-functional teams and works with stakeholders to manage the review and preparation of regulatory submissions
Writes, edits, and compiles documents in support of Agency meetings (e.g., prepares meeting requests and briefing documents)
Supports global business partners for regulatory filings, life-cycle strategy, and related activities
Monitors impact of changing regulations on submission requirements and updates internal stakeholders
Lead the organizations to formulate quality standards and regulations for employees and for the product produced
Develop and manage a robust QMS system
Manage internal and external quality audits
Work Experience, Skills and Education Required:
BA/BS (or equivalent) in pharmacy, chemistry, biology, or a related science field and 10+ years of relevant Regulatory Affairs experience (Regulatory Affairs certification or MA/MS in Regulatory Affairs desired).
10+ years of relevant Regulatory Affairs experience. Regulatory submissions experience required.
Experience working at various stages of development; smaller organization experience is desirable
Regulatory Subject Matter Expert (SME) with in-depth familiarity with a variety of the field's concepts, practices, and procedures.
Strong knowledge of regulatory agency regulations and industry standards.
Excellent verbal, written, strong organizational skills and time management skills.
Must have strong attention to detail and skill in compiling/reviewing submission documents to ensure compliance with regulatory expectations/requirements.
Competent computer skills with MS Office products.
Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
This position may require occasional travel out-of-area and overnight, as needed.
Email Job