Job Details

Requisition Number 20-0055
Post Date 2/4/2020
Title Regulatory Affairs Associate
City Woodcliff Lake
State NJ
Description 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!


POSITION PURPOSE

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 strategies, 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, as needed.



ESSENTIAL FUNCTIONS

• Plan, coordinate, and prepare regulatory submissions (including NDAs, Supplements, IND amendments, Annual Reports, DINs and NPNs), scientific documents and technical information for new, current, and modified drug products and medical devices for the U.S and Canada.
• Review Annual Product Review reports for drugs and devices sold in the U.S and Annual Safety Reports (PBRERs) for drugs sold in Canada.
• Review ingredients and labeling materials for regulatory compliance; advise the business accordingly.

BASIC DUTIES

a. Evaluate data for acceptability and compliance; such as comparability, bridging, stability, safety and / or claim substantiation.
b. Participate in cross-functional meetings to ensure that the necessary scientific data, studies, documentation and information are available in a timely manner to support product registrations.
c. Act as SME across the organization to facilitate greater understanding of the Regulatory requirements for drugs and medical devices.
d. Help maintain U.S and Canada Site Establishment Licenses for Drugs and Medical Devices.
e. Monitor new global regulatory requirements for Drugs and Medical Devices and assess impact to the business.
f. Help maintain Regulatory Intelligence database, regulations, guidance and standards that apply to PDI.
g. Support process improvement and compliance initiatives, including revising current SOPs and Work Instructions as needed to ensure compliance with current requirements.

Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
• Bachelor’s Degree preferably in toxicology, chemistry, biology with at least 3 years of related experience in Regulatory Affairs.

REQUIRED KNOWLEDGE:
• Strong knowledge of U.S regulatory requirements for pharmaceutical products, OTC drugs and medical devices. Other regions is a plus.
• Scientific knowledge of applicable areas to the U.S regulatory process for registration of new drug products (INDs and NDAs), OTC (drug listings), and Medical devices (510(K)s). Experience working with Canada registrations is highly desired and other regions is a plus.

EXPERIENCE REQUIRED:
• Minimum of 3 years of demonstrated regulatory experience working effectively with FDA regulated products. Experience working with other government agencies, such as Health Canada, European Commission, EMA or EPA, is a plus.
• Demonstrated experience with IND and NDA submissions (eCTD format is a plus).
• Experience interfacing with Regulatory Authorities is a plus.

SKILLS/ABILITIES:
• Ability to collaborate cross-functionally to develop and implement regulatory pathways.
• Highly developed written and oral communication skills.
• Able to follow directions and be accountable for work assigned.
• Must have a team attitude.
• Proficient in Microsoft Office applications.


#LI-PDI
#LI-SC2


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.
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.



  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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