172022.01

Global program regulatory director

Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product s and the needs identified by the business, markets and patients.

This includes health authority engagement strategy and considerations of expedited regulatory programs. Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself. Participate in coaching, and performance feedback to members of your GRST. May depending on role and project represent Regulatory Affairs on Global Product Teams GPTs providing strategic Regulatory advice and be accountable for all Regulatory activities Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.

Lead preparation of the regulatory strategy document and target product labeling. Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST. Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.

Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired.

Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus. A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development. Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

The ability to think strategically and critically and evaluate risks to regulatory activities. Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Ability to work strategically within a complex, business critical and high-profile development program. Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components Salary: Competitive We are eager to know more about you.

For more information please contact Alexander. This includes health authority engagement strategy and considerations of expedited regulatory programs. Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.

Participate in coaching, and performance feedback to members of your GRST. May depending on role and project represent Regulatory Affairs on Global Product Teams GPTs providing strategic Regulatory advice and be accountable for all Regulatory activities Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.

Accountable for product maintenance, supply and compliance activities associated with marketed brands. At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions.

Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus. A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. The ability to think strategically and critically and evaluate risks to regulatory activities.

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Ability to work strategically within a complex, business critical and high-profile development program. Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components Salary: Competitive We are eager to know more about you.

For more information please contact Alexander. Share this job Facebook Twitter LinkedIn. Save job Click to add the job to your shortlist.

Bioprocess Development Cell Biology Chemical Engineer Director Research and Development Electrical engineer Molecular Biology Organic Chemistry Synthetic Chemistry Virology Sales and Marketing Business Development Medical Liaison Product Management Project Management Sales Engineering.

United States. Texas TX. That was Regulatory Affairs in We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them.

Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

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