Global Regulatory Strategy Lead - San Diego, CA | Biospace
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Global Regulatory Strategy Lead

BioPhase Solutions Inc.

Location:
San Diego, CA
Posted Date:
6/8/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management, Clinical Project Manager, Clinical Research, Clinical Trial, PhD, Regulatory, Regulatory Affairs,

Job Description

BioPhase Solutions specializes in recruiting talented professionals for San Diego's Scientific and Clinical Research community. We currently have an opening for a Global Regulatory Strategy LeadAssociate with experience in the Biopharmaceutical industry.


Summary:
The Global Regulatory Strategy Lead will have leadership responsibility for global regulatory strategy within a Product Development Team.  They serve as team lead or co-lead of marketing application submission teams for indications that are in late-stage development.

Responsibilities:
•   Lead the development of strategy and content for global dossiers.
•   Develop target labeling and co-lead the cross-functional labeling team.  Ensure consistent positions are presented in responses to global Health Authorities queries.
•   Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
•   In collaboration with the EU regulatory lead, develop global submission plans and HA interaction plans.
•   Provide input into the development of protocol synopses and protocols.
•   Co-lead the cross-functional response teams to respond to IND and Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
•   Lead the development of regulatory pathways and plans for product registration, including associated risk assessments and identification of precedence.
•   Drive the creation and execution of the global submission plan.  
•   Support effective interactions with HAs globally.  

Requirements

Requirements:
•   Solid scientific background: Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience.
•   Significant knowledge of the drug development process
•   Experience in successfully leading submission teams
•   Understanding of and experience in developing regulatory strategy across the clinical, marketing, product development and commercialization process.
•   Understanding of policy, laws, regulations and guidelines as they apply to HAs globally for drug development and approval.
•   Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management.