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Regulatory Affairs Associate Location: US-NJ-Woodcliff Lake Email this job to a friend
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Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Regulatory Affairs Associate will, with his/her management and in collaboration with the cross-functional team, advance business objectives through development of Regulatory pathways/positions and execution of registrations and regulatory submissions. While the primary focus of the position is to obtain US State EPA registrations, international compliance knowledge is a plus. Together with the Regulatory manager, he/she will also provide guidance on product claims, label requirements and communicate on new and changing regulations potentially impacting the business. This is an ideal opportunity for any individual looking to leverage and develop his/her regulatory expertise, with an opportunity for career advancement in a dynamic, fast-paced, and challenging work environment. ESSENTIAL FUNCTIONS AND BASIC DUTIES - Ensures that all regulatory activities related to the maintenance of existing products and the development of new products are conducted and delivered in a compliant manner and with high quality
- Provides regulatory guidance on Disinfectants/Biocides and general cleaners primarily for US States; knowledge of Canadian regulatory requirements (desired); knowledge of EU and Asian regulatory requirements (a plus)
- Obtains product registrations and regulatory approvals in consultation with line manager and with outside consultant where needed
- Reviews claims, labeling, materials, and collateral for compliance and advises the business accordingly
- Acts as a SME across the organization to facilitate greater understanding of the Regulatory Environment and emerging regulations
- Maintains a collaborative relationship with regulatory agencies to obtain timely approval of applications and registrations
PERFORMANCE MEASUREMENTS - Achievement: Ability to deliver technical work on time, without issue and in a quality manner
- Ownership: Ability to demonstrate strong ownership of assigned projects and project work ability to work independently
- Partnership Skills: Ability to work well cross-functionally, communicate effectively and work as part of a team to achieve objectives
- Entrepreneurial Skills: Ability to demonstrate creativity in the role, explore new and more efficient ways of working and contribute new product ideas
Requirements QUALIFICATIONS EDUCATION/CERTIFICATION: - BA/BS degree in the natural sciences (preferred)
REQUIRED KNOWLEDGE: - US Federal and State EPA Regulatory requirement knowledge and state filing (required)
- Knowledge of International regulatory requirements for consumer and biocidal/disinfectant products (a plus)
EXPERIENCE REQUIRED: - A minimum of 3-5 years of relevant work experience
- Experience in disinfectant state EPA registration a must
- State Regulator experience a must
- Prior work experience in the consumer products industry preferred
SKILLS/ABILITIES: - Strong people skills and ability to work effectively within a team
- Initiative-taking and results oriented with a bias for detail
- Ability to multi-task, with strong time management skill
- Ability to display agility and adapt to change
- Excellent communication and networking skills
- Proactive, independent and a willingness to take on new challenges
Benefits - Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Wellness Resources
NicePak Products Inc./ PDI
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