Director, Global Regulatory Affairs Clinical Strategy
Ascendis Pharma
Summary
The 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.
Job description
Key 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.
Knowledge, Skills and Experience
- Minimum of 10 years overall regulatory experience, and preferably including experience managing investigational and marketed products.
- Bachelors Degree required.
- Prior experience representing Regulatory Affairs on cross-functional teams is desirable; Must be capable of effectively leading teams in preparation of submissions.
- Experience working on international teams desirable.
- 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.
- Experience with drug-device combination products preferred, but not required.
- 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; experience with BLAs/NDAs/MAAs a plus.
Requirements
- Minimum of 10 years overall regulatory experience
- Bachelors Degree required
- Prior experience representing Regulatory Affairs on cross-functional teams is desirable
- Must be capable of effectively leading teams in preparation of submissions
- Experience working on international teams desirable
- Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements
- Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
- Experience with drug-device combination products preferred, but not required
- 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
- Experience with BLAs/NDAs/MAAs a plus
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- Pet Insurance
- Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account
- Flexible Spending Accounts
- Incentive Compensation Plans
- Accident, Critical Illness, Hospital Indemnity
- Mental Health Resources
- Paid Parental Leave
Company overview
Ascendis Pharma is a global biopharmaceutical company founded in 2007 and headquartered in Hellerup, Denmark, with additional facilities across Europe and the United States. The company is publicly traded on Nasdaq under the symbol ASND. Ascendis Pharma specializes in applying its innovative TransCon technology platform to develop novel therapies that address unmet medical needs in endocrinology rare diseases and oncology. The company's core values of Patients, Science, and Passion guide its mission to create potentially best-in-class therapies. Ascendis has two marketed products: SKYTROFA (lonapegsomatropin-tcgd) for pediatric growth hormone deficiency and YORVIPATH (palopegteriparatide) for adult hypoparathyroidism. The company's pipeline includes TransCon CNP for achondroplasia and oncology candidates like TransCon TLR7/8 Agonist and TransCon IL-2 β/γ. With approximately 1,017 employees globally as of December 2024, Ascendis operates through a combination of direct commercialization in key markets and strategic partnerships in regions like Greater China and Japan through VISEN Pharmaceuticals and Teijin Limited, respectively.