Global Regulatory Lead
Proclinical is currently recruiting for a Global Regulatory Lead for a multinational biotechnology company located in Cambridge, MA. Successful candidate will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy.
- Direct global regulatory strategies for assigned projects and programs.
- Lead 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.
Skills and Requirements:
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Zachary Hines at (+1) 215-531-6914 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.