Manager, Regulatory Affairs - Job ID: 1322

March 29

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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 supporting and developing global regulatory strategies for the oncology pipeline products encompassing clinical, non-clinical and CMC disciplines. • Ensures timely preparation of organized and scientifically valid submissions. • Provides support in translating regulatory requirements into practical, workable plans for project teams with international participants. • May mentor other regulatory and cross-functional professionals working on the project team on regulatory process-related topics. • Requires ability to work both independently and in a team environment.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced degree desirable. • Minimum of 4 years of direct regulatory affairs experience in the biopharmaceutical industry. • Oncology regulatory experience a plus. • Effectively lead teams in preparation of investigational and marketed products submissions. • Experience working on international teams desirable. • Demonstrate solid knowledge of regulatory requirements, including ICH and regional requirements, and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business. • Review technical documents and influencing colleagues across functions. • Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with EU CTRs, BLAs/NDAs/MAAs a plus. • Ability to travel up to 10% 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