Director, Regulatory Affairs - Pharmaceuticals

Stryker

5d•$167,000 - $362,100•Remote

About The Position

The Director, Regulatory Affairs - Pharmaceuticals provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit’s drug product. Interacts with the business unit’s cross-functional leadership team to support the direction, strategy, and growth of the organization, specifically related to the business unit’s drug and combination product(s). Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.

Requirements

Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
Minimum 15 years of experience, including 10 years in an FDA regulated industry
Ability to analyze complex data
Ability to analyze and understand regulatory requirements and standards
Ability to communicate and present to various stakeholders, both internally and externally
Strong organizational skills
Self-initiated
Demonstrated ability to lead complex cross functional teams and projects

Nice To Haves

RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
5 years of managerial experience preferred
Experience with successful NDA and DINAs.
Prefer additional experience with IDEs/ 510(k)s and/or combination products.

Responsibilities

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level.
Creates long term regulatory strategy for drug products, provides input on combination products, and identifies team needs by understanding the industry and regulatory landscape in combination with the business priorities and goals.
Manages a regulatory affairs team responsible for the division’s pharmaceutical products. Hires, trains, develops, coaches/ mentors and motivates staff. Conducts performance management.
Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally. Regulatory pathways may include INDs, NDA or sNDA, DINAs, etc.
Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
Leads team in development and implement pharmaceutical quality system and process requirements for business in order to ensure compliance to external regulations and standards.
Responsible for commercial drug product disposition and release in addition to Quality Assurance responsibilities.
Viewed as pharmaceutical regulatory expert within business.
Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.
Represents pharmaceutical aspects in external agency audits/inspections.
Stays abreast of external pharmaceutical regulatory requirements and expectations.