Senior Project Manager
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years), Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree, with an advanced degree preferred, and a minimum of 12 years of experience in the pharmaceutical industry, including at least 8 years in Regulatory Affairs and project management. They must have demonstrated experience in building and leading high-performing project management teams, along with in-depth knowledge of global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines. Strong organizational, communication, and problem-solving skills are essential, as well as excellent leadership and negotiation abilities.
Responsibilities
The Senior Director, Regulatory Project Management will build and develop a robust regulatory project management framework, including designing and implementing training programs and developing resource management capabilities. They will lead, mentor, and manage a team of regulatory project managers, conducting performance evaluations and overseeing resource allocation. This role will provide strategic guidance on regulatory project strategies, oversee preparation and submission of regulatory filings, ensure adherence to global regulatory standards, and drive the implementation of best practices for regulatory project management. Furthermore, they will serve as a liaison between the team and other departments, provide regular updates to senior management, and identify and implement process improvements to enhance efficiency and quality, including exploring digital tools for RPM and submission acceleration.
Skills
Regulatory Project Management
Team Leadership
Regulatory Compliance
Project Strategy
Process Development
Training Program Design
Resource Planning
Global Regulatory Standards (FDA, EMA, ICH)
Moderna
Develops mRNA-based medicines for health
About Moderna
Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treating diseases. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments.
Cambridge, MassachusettsHeadquarters
2010Year Founded
$5,925.5MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
5,001-10,000Employees