Planet Pharma ยท 1 day ago
Regulatory Affairs Associate I
North Chicago, IL
Full-time
Onsite
Entry Level
$28/hr - $38/hr
1+ years expPlanet Pharma is a company focused on regulatory affairs, and they are seeking a Regulatory Affairs Associate I to manage activities for marketed product variations. The role involves authoring and compiling CMC sections, coordinating with functional departments, and ensuring timely preparation of submission documents.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses
Independently facilitate project team meetings
Superior oral and written communication skills
Ability to work cooperatively with all levels and types of global personnel required
Experience working with electronic document management systems
Ability to work independently. Manage multiple projects simultaneously
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary
Detail/accuracy oriented, collaborative and willing to learn
Familiarity with US and other international regulatory requirements for dossiers
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)
Review/approval of engineering study protocols/reports and validation study protocols/reports
Review and approval of manufacturing changes for Class III implantable medical devices
May require an advanced degree and 1-3 years of direct experience in the field
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations
Relies on extensive experience and judgment to plan and accomplish goals
Performs a variety of tasks
May lead and direct the work of others
A wide degree of creativity and latitude is expected
Qualification
Required
Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses
Independently facilitate project team meetings
Superior oral and written communication skills
Ability to work cooperatively with all levels and types of global personnel required
Experience working with electronic document management systems
Ability to work independently. Manage multiple projects simultaneously
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary
Detail/accuracy oriented, collaborative and willing to learn
Familiarity with US and other international regulatory requirements for dossiers
Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
Required Experience: 1-2 years pharmaceutical. 1-2 years cross functional project management
Responsible for managing and compiling CMC sections of marketed product variations
Partner with RA CMC Project Leads and develop module 3 content and project timelines
Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses
Skills for running review meetings for submission documents
Understand CMC expectations including CTD content, structural and formatting requirements
Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)
Review/approval of engineering study protocols/reports and validation study protocols/reports
Review and approval of manufacturing changes for Class III implantable medical devices
May require an advanced degree and 1-3 years of direct experience in the field
Recent experience with Class III implantable medical devices
Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
Knowledge of FDA PMA guidance documents and CFR regulations
Relies on extensive experience and judgment to plan and accomplish goals
Performs a variety of tasks
May lead and direct the work of others
A wide degree of creativity and latitude is expected
Preferred
Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
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