The Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a team of US and/or global regulatory leaders (as assigned). Where possible, and leveraging contemporary mechanisms, a key goal for the role is to ensure the conceptualization, development and implementation of efficient global registration pathways to secure approval as well as maintain and (potentially) expand licenses in one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs.
Primary Responsibilities:
Serve as key corporate regulatory contact and source of regulatory information and guidance for US and other markets as applicable; may serve as US Agent.
Serve as a line manager: constructing and developing a team (as resources are assigned)
Provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.
Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned programs.
Stay abreast of regulatory agency regulations, directives, guidelines and policies, etc. that could have an impact on product development to assess approval pathways and issues.
Identify and communicate all issues to management related to product development that could impact product submission, approval, and product launch.
Set and monitor submission timelines along with other key stakeholders.
Facilitate and lead all communications with Regulatory Agencies / Health Authority as applicable.
Ensure communication with the regulatory body is in accordance with established procedure within the department.
At times, there may be the need for other functional areas to have a discussion with the Health Authority with their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.
Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
Must be involved in writing or to facilitate the authoring of certain regulatory sections of product submissions.
Develops and manages relationships with external regulatory agencies, industry groups and business partners.
As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received.
To compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
Participate in authoring and/or reviewing of the departmental procedure as applicable.
Qualifications:
Extensive global regulatory leadership as demonstrated by experience (> 15 years), milestones reached (e.g., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA, and others)
Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.
Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC)
Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets.
Ability and interest in building and/or working a nimble resourcing environment.