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- 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.
- Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
- 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. Prefer additional experience with IDEs/ 510(k)s and/or combination products.
- Travel approximately 25%
- Manage complex technical questions and navigate through uncertainty
- Mental drive to operate at high level for long project duration
- 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
Director, Regulatory Affairs - Mahwah, United States - Stryker
Description
Work Flexibility: Remote or Hybrid or Onsite
Position Summary:
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.
Essential Duties and Responsibilities:
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.