The Global Regulatory Lead will be responsible for developing and delivering innovative global regulatory strategies for product development, approval, and LCM activities for assigned assets in alignment with the global business strategy. Responsible for developing and executing the Global Regulatory Plan and strategy across major territories and accounting for the requirements of their Health Authorities (including US, EU, JP, and China). Responsibility of leading the regulatory activities for the development, registration, and Life-Cycle Management of Biosimilar asset(s), across multiple indications and/or development stages and for ensuring compliance. Represent the company with domestic and international regulatory authorities, contractors, and corporate partners. Management of outsourcing and vendor management for in-country RA execution, medical/regulatory writing. Provide regulatory support for cross product activities/workstreams, input into regulatory policy, and across various projects teams, functions, partners, and committees. Steering and supporting regulatory team members and/or direct reports (as applicable).
Responsible for directing global regulatory strategies for assigned projects and programs through the development and execution of the GRP.
Direct global pre-clinical and clinical regulatory strategies.
Direct global life cycle management of products.
Support development of the late stage clinical development plan and advise on CTA submission strategy.
Set strategic direction and lead global regulatory submission process with submission teams, including marketing applications and core briefing packages.
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.
Develop and maintain the Core Data Sheet and lead global labelling team meetings.
Collaborate closely with Regulatory CMC on related filing content, strategies and risk mitigations.
Assess impact of proposed CMC changes to licenses or clinical trial applications.
Actively promote relationship building across teams.
Direct the organization and preparation of clear and effective submissions.
Prepare and deliver effective presentations for internal and external audience.
Monitor and analyse appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
Mentor and guide team members and/or 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.
Foster a global view as part of the whole regulatory team.
Take steps to actively improve interdepartmental communications.
Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
Is likely to have presence on external regulatory committees/trade associations.
BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject is required.
8 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 6 years in Regulatory Affairs (Strategy).
Experience working on products regulatory aspects of products in pre-clinical and clinical development.
Late stage development regulatory experience, including leading a significant submission (eg NDA or BLA, MAA). Prior experience as a regional regulatory lead, ideally US and/or EU in pharma.
Direct experience in interfacing with relevant regulatory authorities (e.g. FDA, EMA, and PMDA).
Experience in European regulatory pathways for Biosimilars and previous experience in filing.
Good knowledge of applicable regulations and 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 multidisciplinary teams.
Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports (as applicable).
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