Principal Regulatory Affairs Specialist - Cypress, United States - USA 2022-104

Job Title

Principal Regulatory Affairs Specialist

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Cypress
Home/Office based
Office based

Professional Family: 

  • Legal
Reporting To
Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2022-104

Job Scope

Your Mission

For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

DiaSorin Molecular, LLC is headquartered in Cypress, Ca. Our technology enables diagnosis of disease by detecting specific RNA and DNA sequences. We focus on design, development and cGMP Manufacturing.

Main Responsibilities

Your Contributions

We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.

What you will do:
Responsible for compliance to FDA and other applicable regulations; prepares, analyzes, and submits dossiers to various governing agencies in supporting business growth.

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross functional teams.
• Acts as company representative, developing and maintaining positive relationships with reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
• Develops and implements regulatory strategies for new and modified products.
• Acts as an influential member on core teams, providing regulatory feedback and guidance throughout the product development cycle and coordinates team inputs for submissions.
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation where required.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Bachelor’s degree in a scientific or technical discipline.
Experience

What you bring to the table:
5 or more years of progressively more responsible Regulatory Affairs experience required. In vitro diagnostics experience highly desirable.
• Must have knowledge of U.S. and/or European/International regulations and standards, and
experience in preparing regulatory submissions on drug, device, and biologic products is desired.
• Must have prior experience interacting with FDA staff and/or other regulatory agencies and
demonstrated success in securing regulatory approvals.
• Must be able to work well in team environment with individuals from diverse functional areas, as well as independently. Must demonstrate leadership, influencing and advisory capability.
• Should have experience working on project/product from concept to market introduction.
• Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends.
• Should have experience in negotiation of technical issues with internal and external functions
including health authorities.
• RAC preferred but not required.
• The employee must occasionally lift and/or move up to 10 pounds.

Technical Competencies

• Must be detailed oriented. Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations. Requires ability to speak effectively before groups of customers or employees of organization. Requires the ability to organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms. Requires ability to understand and interpret regulatory requirements and technical standards. Must have the ability to write and organize complex reports and correspondence to regulatory agencies. Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations. Requires ability to edit and proof documents with detailed accuracy. Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
• Must have analytical reasoning and problem solving ability. Must be able to analyze quantitative information.

Skills

• Must have experience working with moderate to complex statistical techniques. Must
have ability to calculate dilutions, titrations, and other laboratory methodologies. Must be skilled in basic algebra and geometry. Must be able to perform unit conversions. Must be able to tabulate random data and translate data into text conclusions.
• Must have the ability to define problems, collect data, establish facts, and draw valid conclusions. Must have the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Must use logical thought processes and deductive reasoning. Must have the ability to apply rational sense to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several variables in non-standardized situations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work.

Languages
English
Travel Availability
NA
Relocation Availability
NA
Training Required

YES

Benefits

We Offer You

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Others Information as per Local Legal Requirements

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal Employment Opportunity

Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482.