Lead, Regulatory Safety

The Regulatory Safety Lead will be responsible for leading the compliance for the regulatory requirements relating to  the Company’s post-market product safety surveillance program with applicable regulations. The Regulatory Safety Lead’s duties include coordinating with company management or other key stakeholders to identify potential consumer safety regulation compliance risks, implementing policies and procedures to uphold new or developing laws and regulations, and monitoring the company’s adherence to those policies and procedures.

HOW YOU WOULD CONTRIBUTE: (Responsibilities and tasks associated with the job) *limit to 8-10 bullets 
-    Manage the implementation of regulatory intelligence
-    Manage the expansion of training program to QPPVs globally and implement regulatory training program to GPMSA teams
-    Oversee the implementation of safety risk management for product innovation projects under development (PFR phase) in order to prevent delays throughout project life cycle, identify the risks in early stages of the process, address the risks, and launch products that will be safe for consumers. 
-    Oversee Global Advisory Statement Review (ASR) Process on the portion corresponding of GPMSA
-    Manage and develop regulatory documentation; manage the expansion of regulatory safety documentation SOPs, oversee the development of a database with reporting forms in order to expedite regulatory submissions.
-    Oversee post-market safety surveillance on publicly available databases with the goal of maintaining regulatory compliance and anticipating inquiries from government bodies; manage monitoring of Argus Safety Database for AE/SAE cases
-    Manage the development of local policies for adverse event monitoring; implement and manage regulatory strategies and processes for handling product recalls and communicate with stakeholders with the purpose of expediting GPMSA response

WHAT’S SPECIAL ABOUT THE TEAM: (Give insight to the team dynamic and environment)
This position will be part of a fast-paced, dynamic, and diverse Global Post-Market Safety Affairs team that leads the brand protection and promotion and business growth through surveillance and monitoring, technical assessment, communication with stakeholders and customers, and compliance. It offers opportunities to work with cross-functional global teams across various areas of the business, including regulatory affairs, government affairs, legal, R&D, quality, marketing, and external stakeholders.

SUPERVISORY RESPONSIBILITIES: (Share supervisory duties, if applicable)
•    Supervisory of at least one report 
•    Supervisory activities over time sensitive projects

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: (List requirements, including education and experience needed for the job) *limit 6-7 bullets
•    Excellent analytical thinking and troubleshooting skills; ability to prioritize and action critical projects and effectively manage multiple projects simultaneously
•    Excellent interpersonal and communication skills with all levels, up through executive management
•    Ability to work effectively/independently and as a team player cross-functionally with other departments both at corporate and regional offices
•    3 years work experience in consumer or product safety or quality regulation, which includes leading cross-functional teams and/or regulatory (and compliance) projects involving safety or quality vigilance
•    Comprehensive understanding of clinical/medical and regulatory terminology as determined by degree completion in health, law, or medical science and/or experience in the practical application of these competencies
•    Experience using safety, quality, or product development database software applications 
•    Regulatory readiness and compliance implementation experience

Education
•     Minimum Bachelors degree in subject area described above (e.g. food law, nutrition, pharmacology, or other bio/medical science) and relevant nationally accredited regulatory certificate program completion (e.g. RAPS, MedDRA, etc)