Stryker
Director, Regulatory Affairs - Pharmaceuticals
Posted Date: 01 Pension, 2026. This role was posted for a minimum of 3 days.
Position Summary The Director, Regulatory Affairs – Pharmaceuticals provides leadership, people management, and technical expertise forpick on the regulatory affairs team supporting the business unit’s drug product. SherixInteracts with the business unit’s cross‑functional leadership team to support the direction, strategy, and growth of the organization, specifically relating to the business unit’s drug and combination product(s亚洲综合Responsible for drug development, including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
律宾 Essential Duties and Responsibilities
Serves as member of the extended business unit leadership team and communicates effectively with leadership.
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 business priorities.
Manages a regulatory affairs team responsible for the division’s pharmaceutical products; hires, trains, develops, coaches/mentors and motivates staff, and conducts performance management.
Accountable for regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
Provides regulatory guidance to and collaborates with Marketing, Clinical, Legal, Operations, Compliance, and R&D leadership.
Leads team in developing and implementing pharmaceutical quality system and process requirements for business to ensure compliance to external regulations and standards.
Helps manage commercial drug product disposition and release in addition to Quality Assurance responsibilities.
Represents pharmaceutical regulatory matters in external agency audits/inspections and leads communication with FDA and other regulatory agencies.
Stays abreast of external pharmaceutical regulatory requirements and expectations.
Education & Special Trainings
Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related field.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Qualifications & Experience
Minimum 15 years of experience, including 10 years in an FDA regulated industry.
5 years of managerial experience preferred.
Experience with successful NDA and DINAs, plus preferably IDEs/510(k)s and/or combination products.
Travel approximately 25%.
Manage complex technical questions and navigate uncertainty.
Micias„ mental drive to operate at high level for long project duration.
Ability to analyze complex data and understand regulatory requirements.
Ability to communicate and present to various stakeholders, internally and externally.
Strong organizational skills.
Self‑initiated.
Demonstrated ability to lead complex cross‑functional teams and projects.
Salary and Benefits $167,000 to $362,100 salary plus bonus eligible. Generally eligible for short‑term and long‑term financial incentives, plus benefits. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes. Employees in sales and field roles that require customer access may be required to obtain vaccinations as an essential function of their role.
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Position Summary The Director, Regulatory Affairs – Pharmaceuticals provides leadership, people management, and technical expertise forpick on the regulatory affairs team supporting the business unit’s drug product. SherixInteracts with the business unit’s cross‑functional leadership team to support the direction, strategy, and growth of the organization, specifically relating to the business unit’s drug and combination product(s亚洲综合Responsible for drug development, including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
律宾 Essential Duties and Responsibilities
Serves as member of the extended business unit leadership team and communicates effectively with leadership.
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 business priorities.
Manages a regulatory affairs team responsible for the division’s pharmaceutical products; hires, trains, develops, coaches/mentors and motivates staff, and conducts performance management.
Accountable for regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
Provides regulatory guidance to and collaborates with Marketing, Clinical, Legal, Operations, Compliance, and R&D leadership.
Leads team in developing and implementing pharmaceutical quality system and process requirements for business to ensure compliance to external regulations and standards.
Helps manage commercial drug product disposition and release in addition to Quality Assurance responsibilities.
Represents pharmaceutical regulatory matters in external agency audits/inspections and leads communication with FDA and other regulatory agencies.
Stays abreast of external pharmaceutical regulatory requirements and expectations.
Education & Special Trainings
Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related field.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Qualifications & Experience
Minimum 15 years of experience, including 10 years in an FDA regulated industry.
5 years of managerial experience preferred.
Experience with successful NDA and DINAs, plus preferably IDEs/510(k)s and/or combination products.
Travel approximately 25%.
Manage complex technical questions and navigate uncertainty.
Micias„ mental drive to operate at high level for long project duration.
Ability to analyze complex data and understand regulatory requirements.
Ability to communicate and present to various stakeholders, internally and externally.
Strong organizational skills.
Self‑initiated.
Demonstrated ability to lead complex cross‑functional teams and projects.
Salary and Benefits $167,000 to $362,100 salary plus bonus eligible. Generally eligible for short‑term and long‑term financial incentives, plus benefits. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes. Employees in sales and field roles that require customer access may be required to obtain vaccinations as an essential function of their role.
#J-18808-Ljbffr