Associate Director/Director, International Regulatory Affairs
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Location
San Francisco
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Sector:
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Job type:
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Contact:
Nikita Madan
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Contact email:
n.madan@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
7 months ago
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Expiry date:
2020-07-10
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Startdate:
ASAP
Seeking a regulatory professional who will be responsible for leading the global regulatory strategy for expansion of our development product(s) into international markets.
Responsibilities
- Develop global regulatory strategy (including clinical/nonclinical, CMC and global labeling) for product(s)that are in alignment with overall global product strategy, market timing plans and corporate goals
- Participate/lead regional health authority meetings
- Lead preparation of regulatory documentation especially clinical/nonclinical content for global markets in partnership with Regulatory regional leads and GRL
- Lead the development of global dossier strategy to support international marketing applications for assigned product
- Participate/lead relevant functional area and project team meetings
Experience/Skills
- 10-15years of industry experience in Regulatory Affairs or a related discipline
- Prior experience as a Global Regulatory Lead
- Ability to develop and maintaining strong connections with regional and country leads
- Regulatory information expert with prior experience developing product approval strategies
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Prior experience managing regulatory submissions to deadlines
- Experience managing a small team or at a minimum management in a matrix setting
Education
• BA/BS degree in life sciences
• Advanced degree a plus