Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Senior Manager, Regulatory Affairs will provide leadership within the Hollister Regulatory organization developing regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations. The Senior Manager will work collaboratively with cross functional business partners to execute global strategies, and with external regulatory authorities managing submissions for the US, Canada and European Markets.
The Senior Manager, Regulatory Affairs is also responsible for managing staff supporting the Hollister Emerging Market (EM) strategy and is expected to bring innovative capabilities for managing EM registration and license maintenance activity, as well as staff development.
The Senior Manager, Regulatory Affairs will maintain proficiency on regulations for assigned products and markets, provide continuing awareness on changing regulations, and dissemination of regulatory interpretations to the cross functional business teams including new product development, marketing and clinical groups. This individual will have 2 direct reports.
Serves as leadership within Regulatory Affairs organization to help drive regulatory best practices
Promotes staff development, helping identify areas of development focus and action plans to address
Serves as a strategic business partner working across functions to establish effective product registration strategies
Manages Regulatory Agency interactions to expedite responses to agency queries and approval of applications.
Reviews product labeling and promotional materials to assure compliance with regulatory requirements and consistency with product indications and classification.
Brings vision and innovation to Regulatory Affairs registration and license maintenance activity for the Emerging Market
Provides direction and oversight of Regulatory Affairs projects assuring business objectives are met in a timely and efficient manner.
Bachelor’s Degree in a scientific discipline required, Advanced Degree desired
8 - 10 years’ experience in Regulatory Affairs, or related field
Demonstrated working knowledge and effective implementation of applicable regulations and standards for the EU, LAA, Asia and Middle East.
Strong oral and written communication skills
Strong interpersonal skills – ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
Experienced staff development and management
Ability to execute on strategic initiatives and manage day to day deliverables
Ability to apply new approaches to problem solving
Demonstrated interest in and understanding of industry developments and trends
Project management skills a plus
Clinical Trial experience a plus
Hollister is an EO employer – M/F/Veteran/Disability
Internal Number: 27076
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.