Planet Pharma ยท 1 day ago
Regulatory Affairs Associate II
Princeton, NJ
Full-time
Onsite
New Grad, Entry Level
$48/hr - $55/hrPlanet Pharma is a company focused on ensuring compliance with regulatory requirements. The Regulatory Affairs Associate II is responsible for maintaining documentation systems, ensuring compliance with regulatory agencies, and supporting the Drug Regulatory Affairs Department's objectives.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements
Ensures compliance to the requirements from regulatory agencies
Maintains the technical and non-technical documentation change system
Assures procedures are in place to classify and maintain records
Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements
May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers
May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched
May maintain extensive knowledge of product information and continuous contacts with local, regional customers
To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional secretarial service and assistance, and to contribute to the achievement of functional objectives
Learns to use basic principals, theories, and professional concepts
Applies company policies and procedures to resolve routine issues
Contacts are primarily with immediate supervisor and other personnel in department or group
Works on problems of routine scope
Follows established policies and procedures
Normally receives detailed instructions on all work
Adherence to the companies policy and guidelines
Project & stakeholder feedback
Qualification
Required
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements
Ensures compliance to the requirements from regulatory agencies
Maintains the technical and non-technical documentation change system
Assures procedures are in place to classify and maintain records
Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements
May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers
May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched
May maintain extensive knowledge of product information and continuous contacts with local, regional customers
To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional secretarial service and assistance, and to contribute to the achievement of functional objectives
Learns to use basic principals, theories, and professional concepts
Applies company policies and procedures to resolve routine issues
Contacts are primarily with immediate supervisor and other personnel in department or group
Works on problems of routine scope
Follows established policies and procedures
Normally receives detailed instructions on all work
Adherence to the companies policy and guidelines
Project & stakeholder feedback
Preferred
Experience: Operations Management and Execution
Collaborating across boundaries
Cross Cultural Experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase