Job Details

Requisition Number 20-0048
Post Date 2/14/2020
Title Sr. 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

Support pre-market and post-market activities for Drugs and Medical Devices in the US and Canada. Will process site and product registrations, as well as the maintenance of regulatory compliance for approved products during the post-marketing phase. Will assist in preparing regulatory submissions, including IND, NDA, 510(k) and DIN, in compliance with FDA and Health Canada requirements. Responsible for reviewing product ingredients, labels and claims for accuracy and regulatory compliance. Must have strong verbal and writing skills, work independently and attention to details.


ESSENTIAL FUNCTIONS AND BASIC DUTIES


REGISTRATIONS & FILING
a. Author regulatory submissions including NDAs, Supplements, IND amendments, Annual Reports and 510(k)s to be filed with FDA (eCTD experience preferred).
b. Review test reports for regulatory submissions.
c. Review technical documents for accuracy and regulatory compliance.
d. Assist in preparing Health Canada submissions for medical devices and drugs.
e. Assist in creating technical dossiers for product registrations in other markets (e.g. EU).
f. Assist assessing and reporting adverse events for medical device and drugs.

PROJECT MANAGEMENT
a. Collaborate with other functions (e.g. R&D, Procurement, Marketing, Sales) to answer customer’s inquiries and surveys.
b. Attend cross-functional meetings to provide regulatory guidance and support to different projects.
c. Develop and execute Regulatory strategies to bring new products to market according to appropriate regulatory requirements.
d. Review and approve ingredients and labeling materials for Drugs and Medical Devices.
e. Assist in preparing regulatory documents and presentations for internal meetings.
f. Approve controlled documents, including product specifications, protocols and change controls.
g. Write new SOPs and WIs and provide training to other colleagues.

REGULATORY COMPLIANCE/INTELLIGENCE
a. Monitor new global regulatory requirements for Drugs and Medical Devices.
b. Perform impact assessment of new regulatory requirements in the U.S and Canada and communicate to key stakeholders.
c. Help maintain Regulatory Intelligence database, regulations, guidance and standards that apply to PDI.


PERFORMANCE MEASUREMENTS
1. Hit key Regulatory Milestones for all Core Team projects, including new product launches, cost improvement, changes to existing products and market expansion.
2. Ensure that PDI drug products and medical devices comply with all applicable regulatory requirements.
3. All product and site licenses are valid and accurate, new products are registered before launch and registrations for discontinued products are canceled.
Requirements QUALIFICATIONS

• Applicants must have in depth knowledge of drug regulations in the US, while an understanding of Medical Device requirements is highly desired.
• Experience working with IND and NDA submissions is required (eCTD format is a plus). Experience with 510(k) submissions to the FDA is a plus.
• The successful candidate will have 5-plus years of applicable experience in the Pharmaceutical industry for U.S (Canada is a plus), including labeling reviews, regulatory assessments and product registrations.
• Applicants must have experience reviewing technical documents, pre-clinical and clinical data to support regulatory submissions for drug products. Knowledge of Medical Device Quality System Regulations, GMP and ISO 13485 is a plus.
• Experience reviewing raw materials for compliance with regulatory restrictions, such as FDA restricted chemicals, Canada Hotlist, CA PROP65, inventory lists (DSL, REACH) and other state regulations is a plus.
• A successful track record in coordinating and leading multiple projects and experience interacting with multiple and diverse business units is required.

EDUCATION/CERTIFICATION:
• A minimum of a BA/BS degree in life sciences. RAPS Certification is a plus.

REQUIRED KNOWLEDGE:
• In depth knowledge of US Drug regulations and IND/NDA filing requirements is required.
• Understanding of US Medical Device regulations is highly desired.
• Understanding of Health Canada Drug and Medical Device regulations is a plus.

EXPERIENCE REQUIRED:
• Must have a minimum 5 years of Regulatory experience in the pharmaceutical industry (Medical Device industry is a plus).
• Demonstrated experience with IND and NDA submissions in eCTD format.
• Experience with eCTD publishing applications highly desired.
• Experience preparing 510(k) submissions for devices is preferred.
• Experience preparing and submitting DIN/NPN and Medical Device License applications to Health Canada is a plus.

SKILLS/ABILITIES:
• Ability to write, and approve new SOPs and Work Instructions.
• Able to follow directions and be accountable for work assigned.
• Able to work independently, multi-task and prioritize workload.
• Must have a team attitude.
• Must have strong analytical, verbal and writing skills.
• Proficient in Microsoft Office applications.

WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.

#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.

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
  • 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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