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Global Regulatory Lead
The Global Regulatory Lead will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports.
- Duties and Responsibilities:
- Essential Functions:
- Responsible for directing global regulatory strategies for assigned projects and programs.
- Direct global clinical and pre-clinical regulatory strategies.
- Direct global life cycle management of products.
- Support development of the late stage clinical development plan.
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
- Provide regulatory guidance to company personnel throughout the research and development process.
- Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.
- Develop and maintain the Core Data Sheet and lead global labeling team meetings.
- Advise on global CTA submission strategy.
- Direct the organization and preparation of clear and effective submissions.
- Prepare and deliver effective presentations for external and internal audience.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
- Mentor Regulatory Managers and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports.
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
- Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
- Provide input to Regulatory Senior Management teams.
- Maintain a global view as part of the whole regulatory team.
- Additional Functions:
- Take steps to actively improve interdepartmental communications.
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
- May have presence on external regulatory committees/trade associations.
- 8 years pharmaceutical/biotechnology industry experience with technical management experience.
- Minimum of 6 years in RA.
- Comprehensive knowledge of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
- Expert knowledge with respect to the respective regulatory landscapes in the US, EU, and Japan.
- Solid knowledge of GCPs and GLPs.
- Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).
- Foster effective, positive interactions with regulatory agencies, and corporate partners.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrate excellent leadership and communication skills.
- Ability to represent the department in project teams, committees and external meetings.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.
- Well organized, detail oriented, effective written and oral communication skills.
- Supervisory/mentoring experience.
- Ability to guide, train, supervise and prioritize workload of direct reports if applicable.
- Expert knowledge and experience in gene therapy highly desirable.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
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