Pacira BioSciences, Inc.
About Pacira Pacira BioSciences, Inc.
is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.
Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us? Rarely do you have an opportunity to do work that really matters.
What drives us is our mission.
What makes us successful are our people.
At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management.
Be part of our movement, let's pursue excellence together.
Overview:
This role is responsible for ensuring the accurate and timely submission of regulatory documents to health authorities and plays a crucial role in maintaining compliance with regulatory guidelines and optimizing the submission process.
Essential Duties &
Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.
Other duties may be assigned.
Submission Publishing and Management Prepare and publish regulatory submissions, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and variations.
Collaborate with cross-functional teams to compile, format, and publish regulatory submissions in compliance with applicable regulations and guidelines.
Format and compile regulatory documents according to regulatory agency requirements and internal standards.
Review and approve regulatory documents to ensure accuracy, completeness, and consistency.
Liaise with functional source areas to ensure documents are compliant and submission ready.
Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
Ensure the accuracy, completeness, and consistency of regulatory submissions.
Maintain knowledge of current regulatory guidelines and requirements to ensure compliance.
Manage electronic document management systems and publishing tools to facilitate efficient submission processes.
Coordinate with external vendors, such as contract research organizations (CROs) or regulatory consultants, as needed.
Assist in the development and implementation of work processes related to regulatory publishing activities.
Support regulatory inspections and audits by providing requested documentation and information.
Stay updated on industry trends and best practices related to regulatory publishing.
Supervisory
Responsibilities:
This position has no supervisor responsibilities.
Interaction:
This position works closely with employees in all functional areas of the company to provide regulatory guidance and support.
Education and
Experience:
Minimum 5 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products requiredBachelor's Degree with a major in an analytical field of study desirable Knowledge, Skills, and Abilities:
Prior experience in regulatory affairs or publishing within the pharmaceutical, biotechnology, or medical device industryFamiliarity with regulatory guidelines and requirements, such as FDA, EMA, or other relevant authoritiesProficiency in electronic document management systems and publishing tools; Veeva is preferredStrong attention to detail and ability to work with complex documentsExcellent organizational and time management skillsEffective communication and collaboration abilitiesKnowledge of eCTD (electronic Common Technical Document) structure and submission processes Physical Demands:
The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.
Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Benefits:
Medical, Prescription, Dental, Vision CoverageFlexible Spending Account & Health Savings Account with Company matchEmployee Assistance ProgramMental Health ResourcesDisability CoverageLife insuranceCritical Illness and Accident InsuranceLegal and Identity Theft ProtectionPet InsuranceFertility and Maternity Assistance401(k) with company matchFlexible Time Off (FTO) and 11 paid holidaysPaid Parental Leave About the Company:
Pacira BioSciences, Inc.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.
Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us? Rarely do you have an opportunity to do work that really matters.
What drives us is our mission.
What makes us successful are our people.
At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management.
Be part of our movement, let's pursue excellence together.
Overview:
This role is responsible for ensuring the accurate and timely submission of regulatory documents to health authorities and plays a crucial role in maintaining compliance with regulatory guidelines and optimizing the submission process.
Essential Duties &
Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.
Other duties may be assigned.
Submission Publishing and Management Prepare and publish regulatory submissions, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and variations.
Collaborate with cross-functional teams to compile, format, and publish regulatory submissions in compliance with applicable regulations and guidelines.
Format and compile regulatory documents according to regulatory agency requirements and internal standards.
Review and approve regulatory documents to ensure accuracy, completeness, and consistency.
Liaise with functional source areas to ensure documents are compliant and submission ready.
Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
Ensure the accuracy, completeness, and consistency of regulatory submissions.
Maintain knowledge of current regulatory guidelines and requirements to ensure compliance.
Manage electronic document management systems and publishing tools to facilitate efficient submission processes.
Coordinate with external vendors, such as contract research organizations (CROs) or regulatory consultants, as needed.
Assist in the development and implementation of work processes related to regulatory publishing activities.
Support regulatory inspections and audits by providing requested documentation and information.
Stay updated on industry trends and best practices related to regulatory publishing.
Supervisory
Responsibilities:
This position has no supervisor responsibilities.
Interaction:
This position works closely with employees in all functional areas of the company to provide regulatory guidance and support.
Education and
Experience:
Minimum 5 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products requiredBachelor's Degree with a major in an analytical field of study desirable Knowledge, Skills, and Abilities:
Prior experience in regulatory affairs or publishing within the pharmaceutical, biotechnology, or medical device industryFamiliarity with regulatory guidelines and requirements, such as FDA, EMA, or other relevant authoritiesProficiency in electronic document management systems and publishing tools; Veeva is preferredStrong attention to detail and ability to work with complex documentsExcellent organizational and time management skillsEffective communication and collaboration abilitiesKnowledge of eCTD (electronic Common Technical Document) structure and submission processes Physical Demands:
The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.
Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Benefits:
Medical, Prescription, Dental, Vision CoverageFlexible Spending Account & Health Savings Account with Company matchEmployee Assistance ProgramMental Health ResourcesDisability CoverageLife insuranceCritical Illness and Accident InsuranceLegal and Identity Theft ProtectionPet InsuranceFertility and Maternity Assistance401(k) with company matchFlexible Time Off (FTO) and 11 paid holidaysPaid Parental Leave About the Company:
Pacira BioSciences, Inc.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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