Manager Reg Affairs

Summary:

The purpose of the Manager, Regulatory Affairs position is to provide strategic and tactical direction, preparation, and implementation of Regulatory activities for Nice Pak Products. The Manager, Regulatory Affairs will advance business objectives via development of Regulatory pathways and project plans and preparation and execution of Regulatory 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 practice.

Essential Duties and Responsibilities:

Duties may vary between specialists.  This list includes all primary duties shared by Managers.

• Performance Measurements: Project management, regulatory compliance, number of regulatory submissions, number of regulatory approvals, new product launches, team development requirements.
• Implement systems for periodic review, including method updates, testing, and substantiation.
• Plan, coordinate, and prepare regulatory/registration applications, scientific documents and information for new, current, and changing products.
• Review materials and collateral for compliance; advise the business accordingly. d. Prepare and maintain registrations.
• Monitor, report and streamline budget information with a view toward cost reduction.
• Lead the development, review, and execution of study protocols and reports.
• Evaluate data for acceptability and compliance; including comparability, bridging, stability, and claim substantiation.
• Develop and maintain metrics as appropriate for performance and quality.
• Advise the project teams in the development of new products for the growth and expansion of the Enterprise.
• 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.
• Act as SMEs across the organization to facilitate greater understanding of the Regulatory Environment.
• Maintain a collaborative relationship with regulatory agencies to obtain timely approval of pending applications and registrations. Help bi-directionally educate on Nice Pak products to ensure that the company’s interests are protected and represented in the development of new regulations.
• Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, and negotiation of requirements, labeling and risk mitigation.
• Maintain compliance with all regulatory requirements for products that fall under specific Center(s) of Expertise.
• Participate in Trade associations to protect the Nice Pak’s interest and products.
• Maintain knowledge of current ICH, GMP, GLP and GCP regulations and contact with key regulatory authorities.
• Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
• Develop Regulated Documents (SOPs, Corporate Practices, Work Instructions, etc.) to codify Regulatory Affairs responsibilities, processes and procedures.
• Act as Subject Matter Expert (SME) to implement positive change in the Regulatory culture across the Enterprise. 
• Gain experience with electronic submissions and format.
• Attend a minimum of one relevant offsite academic event annually.
• Provide expertise and support to Agency Inspections and Audits.
• Mentor/ develop talent within direct sphere of influence.

Supervisory Responsibilities:

In the absence of Director of Regulatory Affairs may be assigned signature authority.

Education Requirements:

BS, MS or PhD in chemistry, biology, microbiology, nursing, pharmacy or natural sciences or equivalent.

Experience Requirements:

Must have minimum of 5 years of effectively demonstrating regulatory experience in FDA, Health Canada, EU or EPA, registrations, negotiations, and product launches. Must have 4 years of project management/supervisor experience. Experience with interfacing with Regulatory Authorities is a plus.

Competencies:

• Ability to collaborate cross-functionally to develop and implement regulatory pathways.

 • Technical expertise and fortitude to establish and maintain Regulatory Affairs’ prominence as an educator and early partner within product development.

• Ability to construct technically thorough, compliant and persuasive scientific documents to support/ defend regulatory strategies and registrations.

• Highly developed written and oral communication skills

• Proficiency and experience in negotiation and influencing others to change.

• Working experience of the regulatory construct for the appropriate Center of Expertise (COE). Registration process of regulated cosmetic, consumer, pharmaceutical, medical device, food safety 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.

Certificates, Licenses, Registrations:

None

Travel:

Limited

Work Environment:

Normally exposed to typical office environment.  Occasionally, worker exposed to: Extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort, sufficient noise to cause worker to shout to be heard above the ambient noise level, and hazards such as proximity to moving mechanical parts.

Physical Demands:

Occasionally lift boxes of product 5-40 lbs.  Frequently lift samples 1-5 lbs. Walking, talking, hearing, climbing, reaching, grasping, and standing. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.