Planet Pharma
This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $36.00/hr - $37.00/hr
Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.
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.
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
Responsible for managing and compiling CMC sections of marketed product variations, partnering with RA CMC Project Leads and developing module 3 content and project timelines, collaborating with diverse functional groups to ensure file‑ability and acceptance of CMC sections, and managing assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
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), reviewing and approving engineering study protocols/reports, validation study protocols/reports, and manufacturing changes for Class III implantable medical devices.
Qualifications
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 and manage multiple projects simultaneously.
Detail/accuracy oriented, collaborative and willing to learn.
Familiarity with U.S. 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 in pharmaceutical; 1‑2 years in cross‑functional project management.
Preferred experience: 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Experience level: 1‑3 years.
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.
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North Chicago, IL .
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Base pay range $36.00/hr - $37.00/hr
Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.
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.
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
Responsible for managing and compiling CMC sections of marketed product variations, partnering with RA CMC Project Leads and developing module 3 content and project timelines, collaborating with diverse functional groups to ensure file‑ability and acceptance of CMC sections, and managing assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
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), reviewing and approving engineering study protocols/reports, validation study protocols/reports, and manufacturing changes for Class III implantable medical devices.
Qualifications
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 and manage multiple projects simultaneously.
Detail/accuracy oriented, collaborative and willing to learn.
Familiarity with U.S. 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 in pharmaceutical; 1‑2 years in cross‑functional project management.
Preferred experience: 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Experience level: 1‑3 years.
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.
Get notified about new Regulatory Affairs Associate jobs in
North Chicago, IL .
#J-18808-Ljbffr