Job Details

ID #6102634
Estado Massachusetts
Ciudad Cambridge
Tipo de trabajo Full-time
Salario USD TBD TBD
Fuente Biogen
Showed 2020-11-25
Fecha 2020-11-25
Fecha tope 2021-01-24
Categoría Etcétera
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Director, Global Regulatory Lead

Massachusetts, Cambridge, 02138 Cambridge USA

Vacancy caducado!

Job Description

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.

II. Duties and Responsibilities:A. 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.

B. 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.

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Qualifications

Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).

8 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 6 years in Regulatory Affairs (Strategy). 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. Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).

Experience in interpretation of regulations, guidelines, policy statements, etc. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

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. Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports if applicable. Expert knowledge and experience in gene therapy highly desirable.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Vacancy caducado!

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