The Senior Manager, Strategic Regulatory Affairs will provide leadership within the Hollister Regulatory organization, managing a team of regulatory professionals to assure successful New Product Commercialization support, from early development through major market product launch.
The Senior Manager will work with staff to provide regulatory guidance and influence project teams to assure development of appropriate data and documentation for submission, and oversee strategy execution in line with the project team goals.
The Regulatory Affairs Senior Manager will maintain proficiency on regulations, guidance and agency action for Hollister major markets, and partner with business leads to provide continuing awareness on changing regulations relevant to the business teams. This role will be responsible for leading preparations for communications and interactions with FDA, NSAI and Health Canada.
As a leader of people, competency and focus on overall team development is imperative for success in this position.
Serves as leadership within Regulatory Affairs organization to help drive regulatory best practices
Develops global regulatory strategies, identifies and proposes risk mitigations and influences project teams and sub-teams for appropriate data development
Research and interpret regulatory decisions in a similar product category to assess regulatory approval implications
Provides assessment of changing regulations and guidance, and identifies any needed changes to internal policies, processes, or practice
Maintains up to date knowledge of regulatory requirements, contributes comments on draft regulatory guidance and communicates changes in regulatory practice to project teams and senior management
Works with marketing to develop new advertising, concept review comment and approval, competitive challenge research and responses
Supports post market product changes through evaluation of impact to existing licenses and manages as needed, notifiable changes and supplemental dossier development and submission, through to approval
Engages and negotiate with regulatory authorities in line with business needs
Provides input into risk assessments associated with product issues and implement appropriate regulatory steps to address
Promotes staff development, helping identify areas of development focus and action plans to address
Bachelor’s Degree in a scientific discipline required, Advanced Degree desired
Number of Overall Years Regulatory or closely associated experience necessary: 12-15
Demonstrated working knowledge and effective implementation of applicable regulations and standards for the EU, US, Canada, and Australia.
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
Strong leadership skills and ability to influence change
Demonstrated ability to attract, build and motivate a regulatory team of high-functioning individuals
Ability to execute on strategic initiatives and manage day to day deliverables
Ability to apply and cultivate 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: 27456
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical 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.