Job Summary

 

Reporting to the Senior Director of Regulatory Affairs, the Specialist II monitors and analyzes issues in various phases of government regulatory procedures and identifies trends important to the organization for use by management in decision making. The Specialist II is also responsible for the review of promotional materials for compliance with regulatory requirements..

 

Primary Duties and Responsibilities

 

·         Performs review of promotional material and Manages and tracks queries, comments and commitments with regulatory agencies and provides periodic status updates regarding unfulfilled conditions/commitments.

·         Supports processes by which regulatory notifications are reviewed, finalized, and signed-off.

·         Supports commercial product notification activities, as directed.

·         Develops and maintains product dossiers

·         Manages tracking of regulatory notifications and approvals across all projects.

·         Manages document archives and processes for regulatory documents.

·         Transfers regulatory documentation into an electronic documentation system and ensures availability of regulatory information to other departments as needed.

·         Identify and develop necessary standard operating procedures (SOPs) for Regulatory Affairs department to ensure regulatory compliance

·         Participate in and support health authority/government agency inspections (e.g., FDA annual audits and health agency facility inspections)

·         Lead interdepartmental alignment meetings to manage regulatory activities and strategize/plan for timely submissions

·         Lead and collaborate with cross-functional teams to coordinate and implement regulatory submission strategies and content

·         Create, maintain, and update templates for regulatory agency and health agency submissions

·         Lead notification process for new and ongoing regulatory submissions, including planning regulatory strategy, compiling and evaluating data and information, authoring and routing draft notification documents with subject matter experts, preparing and submitting final notification, tracking and managing submission to closure, and maintaining submitted notifications for future reference.

·         Review and recommend changes on proposed product labels/labeling, promotional material, other marketing documents, and operations/manufacturing changes to ensure the design/claims/process change/intended use are well supported and domestic/international regulations are met.

·         Communicate with regulatory authorities on matters relating to compliance with applicable laws or regulations, pre-submission strategies, potential regulatory clarification, and/or follow-up on submissions under review

·         Research regulatory issues and disseminate regulatory information to Marketing, Operations, Manufacturing, QA/QC,departments and senior management

·         Other duties as assigned

 

 

Job Requirements and Qualifications

 

·         Regulatory Knowledge (as applicable)

·         Regulatory history, guidelines, policies, standards, practices, requirements and precedents

·         Regulatory agency structure, processes and key personnel

·         Principles and requirements of applicable product laws (Food/Infant Formula)

·         Notification/Submission/registration types and requirements, US, EU and ROW

·         GxPs (GCPs, GLPs, GMPs)

·         Principles and requirements of promotion, advertising and labeling - Note: This knowledge may be developed through tenure in this position.

·         Learn to write and edit technical documents

·         Research and locate information on regulatory requirements and products

·         Handle detailed tasks and prioritize them

·         Meet deadlines

·         Work with people from various disciplines and cultures

·         Review and analyze documentation

·         Exercise judgment and creativity within defined procedures and practices to determine appropriate action

·         Develop general knowledge of technical alternatives and gain an understanding of their impact on associated products, systems and the business.

·         Apply business ethical standards

 

Qualifications

 

·         Advanced degree in the biological or food/pharmaceutical or regulatory sciences preferred.

·         3-6 years of relevant regulated industry experience. Academic research in human milk science is also considered as relevant experience.

·         Knowledgeable of Food and Infant Formula guidance’s, regulations, development process, and industry standard practices is desirable.

·         Proficient in written, oral, and interpersonal communications in English and another Asian language.

·         Ability to work in close collaboration with colleagues cross functionally.

·         High attention to detail; ability to organize and prioritize assigned projects.

·         Experience with documentation and process of regulatory agency notifications in Asia/Pacific region countries is highly preferred.

·         Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.

 

 

Other Knowledge, Skills and Abilities

 

·         Written and Verbal Communication Skills - Communication Skills or Ability to: Communicate effectively verbally and in writing

·         Cognitive Skills - Ability to pay strong attention to detail

·         Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.  Think analytically and critically

·         Detailed oriented and strong organization skill

·         Judgment and Decision Making

·         Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate.

 

Work Environment (Location, travel, shift, on-call, etc.)

The position is located at the company offices in Duarte. The standard work hours are Monday through Friday, between 8 am and 5 pm. Occasional travel to the nearby manufacturing plant in City of Industry is required. This position may require out of town travel of less than 10% of annual work hours.

 

Physical Requirements

 

a.    Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

b.    Physical requirements – Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday.

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Stand		X
Walk		X
Sit				X
Talk or hear			X
Use hands to finger, handle or feel		X
Climb or balance	X
Stoop, Kneel, crouch or crawl	X
Reach with hands and arms		X
Taste or smell	X

 

c.     Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

 

 

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Up to 10 pounds		X
Up to 25 pounds	X
Up to 50 pounds	X
Up to 100 pounds	X
More than 100 pounds	X

 

 

Direct Reports

 

N/A