Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961

Ascendis Pharma•Palo Alto, CA

6d•Onsite

About The Position

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to support your personal development on our journey towards becoming a leading rare disease company. Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. Ascendis Pharma is looking to hire an experienced Associate Director, Regulatory Affairs Clinical Strategy to join our team. This is an exciting opportunity to join a rapidly growing, innovative company! The Associate Director, Regulatory Affairs Clinical Strategy will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work both independently and in a team environment. The position will be based in Palo Alto, CA.

Requirements

Minimum of 8 years overall regulatory experience, and preferably including experience managing investigational and marketed products.
Bachelors Degree required.
Must be capable of effectively leading teams in preparation of submissions.
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.
Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required

Nice To Haves

Prior experience representing Regulatory Affairs on cross-functional teams is desirable
Experience working on international teams desirable.
Experience with drug-device combination products preferred, but not required.
experience with BLAs/NDAs/MAAs a plus

Responsibilities

Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members, including CMC regulatory team members.
Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
Contributes to development of global labeling documents (prescribing information and patient information).
Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams.
Schedules and arranges own activities and those of direct reports.
Work is performed under direction of a Senior Regulatory Affairs professional.