- Responsible for strategic and operational regulatory input and support for cross functional (CMC, non-clinical and clinical) collaboration with other project 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.
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions and approvals associated with assigned projects
- Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs and external to the company.
- 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.
- BS/BA Degree in a Scientific Discipline, Advanced degree desirable.
- Minimum of 4 years of direct regulatory affairs experience in the biopharmaceutical industry.
- 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 have an understanding of 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 BLAs/NDAs/MAAs a plus.
- Ability to travel up to 10% of the time domestically and internationally.
- Salary range: $140-150K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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Manager, Regulatory Affairs: Job ID- 1322 - Palo Alto, CA, United States - Ascendis Pharma A/S
Description
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. 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 are a dynamic workplace for employees to grow and develop their skills.
We promote a trusting and appreciative company culture and value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.
The Manager, Regulatory Affairs will be responsible for supporting and developing global regulatory strategies for both development and commercial 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 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 and reports directly to the Senior Director, Regulatory Affairs.
Key Responsibilities
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
