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Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 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!
The purpose of the Associate, Regulatory Affairs position is to provide tactical direction, preparation, and implementation of Regulatory activities for PDI. The Associate, Regulatory Affairs will, in conjunction with his/ her management, advance business objectives via development of Regulatory pathways and project plans and preparation and execution of registrations and filings. He/ she will ensure compliance for the relevant product classifications for the US, Canada, EU and other global regulatory bodies for product, labeling, policies and practices. Additionally, he/she will provide safety support through responsibility for preparation, issuance and maintenance of safety data sheets.
a. Evaluate data for acceptability and compliance; such as comparability, bridging, stability, and / or claim substantiation.
b. Advise the PDI technical and project teams in the development of new products for the growth and expansion of the Enterprise.
c. Lead and participate in internal and external cross functional teams to ensure that the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner to support regulatory requirements.
d. Act as SME across the organization to facilitate greater understanding of the Regulatory Environment.
e. Maintain a collaborative relationship with regulatory agencies to obtain timely approval of pending applications and registrations.
f. Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, and negotiation of requirements, labeling and risk mitigation.
g. Author, update, publish, and review product Safety Data Sheets (SDS) per regulatory requirements.
h. Assist with continuous process improvement for SDS authoring process.
i. Responsible for maintaining a copy of the most current SDS in the design history file.
j. Maintain an index that identifies all active item numbers with a corresponding SDS number. Index must include common attributes by item number across the chapters of the SDS.
k. Oversee and communicate necessary requirements for ingredient changes and their associated product labeling.
l. Develop risk assessments and polices for oral, dermal, inhalation, eye, skin, and food contact surfaces for product classification.
m. Coordinate Product Safety evaluations and required labeling according to Regulatory guidance, classification, and SOPs for product safety compliance.
Bachelors Degree preferably in toxicology, chemistry, biology, engineering or material science with at least 3 years of related experience. Hazardous Materials Certified preferred but not necessary.
Registration process of regulated cosmetic, consumer, pharmaceutical, medical device, and/or EPA products.
Scientific knowledge of applicable area(s) to the regulatory process for registration of new products in the Category; e.g., drugs, cosmetics, OTC, EPA and/or Medical devices for US, Canada, EU and global markets.
Minimum of 3 years of effectively demonstrating regulatory experience in FDA, Health Canada, EU or EPA, registrations, negotiations and product launches.
Experience with interfacing with Regulatory Authorities is a plus.
Ability to collaborate cross-functionally to develop and implement regulatory pathways.
Highly developed written and oral communication skills
NONE: No hazardous or significantly unpleasant conditions.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system. All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate. In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization. Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Full Benefits starting Day 1
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