Job Details

Requisition Number 19-0088
Post Date 4/15/2019
Title Sr. Director Regulatory Affairs
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

This position is responsible for leading the regulatory activities providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals. Regulatory activities include but are not limited to communications with all regulatory agencies and assist as a liaison between the R&D, Quality, Operations, and commercial groups, ensuring adherence to the objectives and timelines of the R&D and Commercial annual plans.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Develop, maintain and communicate the RA strategy to support New Product and Life-Cycle Management processes in conjunction with the Regulatory Affairs Team. (i.e., regulatory strategy, compliance strategy, etc.)
• Responsible to ensure department is aligned and appropriately structured to support achievement of the annual plan.
• Leads key R&D regulatory and business objectives and ensures implementation.
• Responsible for the recruitment, training, coaching and performance management of associates, creating and promoting an environment of teamwork and empowerment. Ensure the department is staffed with appropriately qualified personnel. Ensures the development of the required competencies of team members for their role and future progression.
• Develops and manages relationships with external regulatory agencies, industry groups and business partners. Acts as key corporate regulatory contact.
• Develops and maintains relationship with internal business partners and key stakeholders to ensure business objectives are met.
• Educates and informs the organization on industry and regulatory trends and the potential business impacts.
• Serve as the source for regulatory information and guidance for all business units. Plan and manage the local regulatory activities.
• Review, evaluate, analyze and recommend actions on all regulatory issues pertaining to product approvals and launch.
• Liaises with Sales and Marketing, Business Development and R&D to provide regulatory strategies during new product planning.
• Maintain up-to-date knowledge on regulatory requirements to assure compliance with current regulations.


PERFORMANCE MEASUREMENTS
1. Successful mapping of Regulatory pathways for active projects
2. Agency approval of submissions – single cycle
3. Effective budget analysis and execution
4. Employee development and engagement
Requirements QUALIFICATIONS


EDUCATION/CERTIFICATION: A minimum of a BA/BS within a scientific discipline is required. Advanced/ terminal degree such as MS, PhD or PharmD is a plus.

REQUIRED KNOWLEDGE: Proficiency in electronic submissions/ electronic filing systems, Microsoft Office/ Lync, SharePoint required.

EXPERIENCE REQUIRED: 15-plus years of applicable experience in the global regulatory affairs environment and at least 10 years of management experience leading professionals. A strong background in pharmaceutical and medical device product approvals is a must.

SKILLS/ABILITIES: • Expertise to strategize, execute, develop and improve regulatory systems for compliance and efficiency
• Ability to react calmly, thoroughly and quickly in urgent situations.
• Leadership that is inspirational and collaborative
• Ability to address new product initiatives outside of company's core product and process technology domain.


WORKING CONDITIONS

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.


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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