Head of Regulatory Affairs, Oncology - Job ID: 1404

May 9

Ascendis Pharma

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We've got making a difference for patients down to a science

Endocrinology • Oncology • Drug Development • Innovation • Globalization

501 - 1000

Description

• Responsible for overarching strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues • Contributes to the development of global clinical regulatory plans and strategies; identifies and proposes risk mitigation strategies; influences project teams and sub teams across international site locations • Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion • Acts as the company representative with regulatory authorities • Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs • Must be willing to provide hands-on, study level help as needed in addition to oversee direct reports • Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines • Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams • Work is performed under direction of the Head of Clinical Development, Oncology • Contributes to internal regulatory policies and procedures to achieve best practices and work processes

Requirements

• BS/BA Degree in a Scientific Discipline required. Advanced Degree preferred • Minimum of 15 years in the biopharmaceutical industry with at least 10 years overall regulatory experience (with at least 6 of those years in Oncology) • Prior Senior Management experience representing Regulatory Affairs on cross-functional teams is desirable. • Must have hands-on experience in successfully leading cross-functional teams for submissions of regulatory dossiers including CTAs, IMPDs, INDs; experience with BLAs/NDAs/MAAs in solid tumors are required; accelerated approval experience a plus • Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business • Must be capable of critically reviewing complex technical documents and influencing colleagues across functions • Ability to travel up to 10-20% of the time domestically and internationally

Benefits

• Medical insurance • Vision insurance • Dental insurance • 401(k) • Paid maternity leave • Paid paternity leave • Commuter benefits • Disability insurance