Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961
Ascendis Pharma
4 hours ago
Remote friendly (Palo Alto, CA)
United States
$185,000 - $205,000 USD yearly
Corporate Functions
Position Summary:
The Associate Director, Regulatory Affairs Clinical Strategy will develop and implement global regulatory strategies across clinical, non-clinical, and CMC. Ensures timely preparation of scientifically valid submissions. Translates regulatory requirements into practical plans for internationally distributed project teams. May mentor and supervise other regulatory professionals. Works independently and in a team environment. Based in Palo Alto, CA.
Key Responsibilities:
- Provide strategic and operational regulatory input for cross-functional (CMC, non-clinical, clinical) areas in collaboration with project teams
- Contribute to global clinical/regulatory plans and strategies; identify and propose risk mitigation; influence teams across international sites
- Develop global labeling documents (prescribing information and patient information)
- Prepare and/or manage technically complex submissions requiring extensive cross-department interaction
- Maintain knowledge of complex regulatory requirements; communicate changes to project teams
- Schedule/arrange own activities and those of direct reports
Requirements:
- Minimum 8 years overall regulatory experience; preferably managing investigational and marketed products
- Bachelor’s degree required
- Desirable: represent Regulatory Affairs on cross-functional teams; lead teams for submission preparation
- Desirable: experience with international teams
- Extensive knowledge of ICH and regional regulatory requirements and global/regional trends
- Ability to critically review complex technical documents and influence across functions
- Preferred: drug-device combination product experience
- Travel: up to 10–20%
- Experience filing dossiers including CTAs, IMPDs, INDs (BLAs/NDAs/MAAs a plus)
Benefits (selected):
- 401(k) with company match; medical/dental/vision; life/AD&D; short/long-term disability; pet and legal insurance; EAP; employee discounts; professional development; HSA; flexible spending; incentive compensation plans; accident/critical illness/hospital indemnity; mental health resources; paid leave for new parents
The Associate Director, Regulatory Affairs Clinical Strategy will develop and implement global regulatory strategies across clinical, non-clinical, and CMC. Ensures timely preparation of scientifically valid submissions. Translates regulatory requirements into practical plans for internationally distributed project teams. May mentor and supervise other regulatory professionals. Works independently and in a team environment. Based in Palo Alto, CA.
Key Responsibilities:
- Provide strategic and operational regulatory input for cross-functional (CMC, non-clinical, clinical) areas in collaboration with project teams
- Contribute to global clinical/regulatory plans and strategies; identify and propose risk mitigation; influence teams across international sites
- Develop global labeling documents (prescribing information and patient information)
- Prepare and/or manage technically complex submissions requiring extensive cross-department interaction
- Maintain knowledge of complex regulatory requirements; communicate changes to project teams
- Schedule/arrange own activities and those of direct reports
Requirements:
- Minimum 8 years overall regulatory experience; preferably managing investigational and marketed products
- Bachelor’s degree required
- Desirable: represent Regulatory Affairs on cross-functional teams; lead teams for submission preparation
- Desirable: experience with international teams
- Extensive knowledge of ICH and regional regulatory requirements and global/regional trends
- Ability to critically review complex technical documents and influence across functions
- Preferred: drug-device combination product experience
- Travel: up to 10–20%
- Experience filing dossiers including CTAs, IMPDs, INDs (BLAs/NDAs/MAAs a plus)
Benefits (selected):
- 401(k) with company match; medical/dental/vision; life/AD&D; short/long-term disability; pet and legal insurance; EAP; employee discounts; professional development; HSA; flexible spending; incentive compensation plans; accident/critical illness/hospital indemnity; mental health resources; paid leave for new parents