Arrowhead Pharmaceuticals
Manager, Regulatory Affairs (MLR Coordinator)
Arrowhead Pharmaceuticals - Pasadena, California, United States, 91122
Work at Arrowhead Pharmaceuticals
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Overview
Manager, Regulatory Affairs (MLR Coordinator)
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Manager, Regulatory Affairs (MLR Coordinator)
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Arrowhead Pharmaceuticals Manager, Regulatory Affairs (MLR Coordinator)
16 hours ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs (MLR Coordinator)
role at
Arrowhead Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Regulatory Affairs MLR Manager is responsible for managing the MLR review and approval process. The Manager will schedule review meetings with the U.S. MLR team as well as the Commercial and Medical Affairs team to ensure timely review, discussion and approval of non-promotional and promotional materials. The manager is responsible for sending out a review meeting agenda of materials to be reviewed prior to the MLR meeting. During the review meetings, he/she will capture all recommended revisions in Veeva and coordinate with the material owner making the revisions to each reviewed item. The manager is responsible for ensuring processes for the review and approval of documents within Veeva are followed and that MLR timelines are met. They will also be responsible for tracking global MLR review materials and coordinating with the global MLR team and their corresponding vendors.
Responsibilities
Act as the primary day-to-day liaison with the MLR reviewers, commercial, med affairs and assigned content owners. Schedule standing and ad hoc MLR review meetings with an agenda sent prior to the meeting. Work with material owner to ensure documents submitted for MLR review in Veeva are ready for review (document is complete, references are provided and annotated as appropriate). Liaise with and guide marketing agencies and document owners on the MLR submission standards. Conduct quality checks of materials submitted for MLR review for completeness and proof the final versions of approved materials for accuracy and completeness relative to MLR requested modifications. Facilitate regular live meetings with the review committee, electronically capture all MLR comments/revisions and provide these to the material owner in Veeva. Follow-up to obtain required approvals, signatures and comments from MLR reviewers Develop and maintain tracking sheets for all materials planned for MLR review. Notify material owner once a document is approved for use. Notify Information Technology to add / deactivate users in Veeva, manage workflows by cancelling or modifying tasks, upload documents/redlines from MLR meeting, remove expired documents Ensure FDA submission required documents are compiled and submission ready in a timely manner; prepare FDA Form 2253.
Requirements:
Bachelor’s degree in Biochemistry, Chemistry, Biology, or related science discipline 7 years of relevant experience in pharmaceutical drug development 5 years in regulatory affairs in supporting/coordinating MLR review Demonstrable experience in successfully developing and managing regulatory submissions, Exceptional organizational skills, ability to multi-task and be detail oriented Strong interpersonal and communication (both oral and written) Works well within diverse groups to achieve common goals Ability to maintain highest degree of professionalism, integrity and diplomacy Strong problem-solving skills and ability to deal with changing priorities Excellent project management skills Proficient in pertinent software & tools (Veeva MedComms and Promomats)
Preferred:
Regulatory Affairs Certification through the Regulatory Affairs Professional Society is Prior experience with the preparation of regulatory submissions, as well as knowledgeable with FDA guidelines relevant to advertising and promotion compliance with marketed products Knowledgeable in industry trends for regulatory submission preparation, including electronic document submissions (i.e., eCTD)
California pay range
$150,000—$175,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal, Other, and Writing/Editing Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Arrowhead Pharmaceuticals by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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Join to apply for the
Manager, Regulatory Affairs (MLR Coordinator)
role at
Arrowhead Pharmaceuticals Manager, Regulatory Affairs (MLR Coordinator)
16 hours ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs (MLR Coordinator)
role at
Arrowhead Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Regulatory Affairs MLR Manager is responsible for managing the MLR review and approval process. The Manager will schedule review meetings with the U.S. MLR team as well as the Commercial and Medical Affairs team to ensure timely review, discussion and approval of non-promotional and promotional materials. The manager is responsible for sending out a review meeting agenda of materials to be reviewed prior to the MLR meeting. During the review meetings, he/she will capture all recommended revisions in Veeva and coordinate with the material owner making the revisions to each reviewed item. The manager is responsible for ensuring processes for the review and approval of documents within Veeva are followed and that MLR timelines are met. They will also be responsible for tracking global MLR review materials and coordinating with the global MLR team and their corresponding vendors.
Responsibilities
Act as the primary day-to-day liaison with the MLR reviewers, commercial, med affairs and assigned content owners. Schedule standing and ad hoc MLR review meetings with an agenda sent prior to the meeting. Work with material owner to ensure documents submitted for MLR review in Veeva are ready for review (document is complete, references are provided and annotated as appropriate). Liaise with and guide marketing agencies and document owners on the MLR submission standards. Conduct quality checks of materials submitted for MLR review for completeness and proof the final versions of approved materials for accuracy and completeness relative to MLR requested modifications. Facilitate regular live meetings with the review committee, electronically capture all MLR comments/revisions and provide these to the material owner in Veeva. Follow-up to obtain required approvals, signatures and comments from MLR reviewers Develop and maintain tracking sheets for all materials planned for MLR review. Notify material owner once a document is approved for use. Notify Information Technology to add / deactivate users in Veeva, manage workflows by cancelling or modifying tasks, upload documents/redlines from MLR meeting, remove expired documents Ensure FDA submission required documents are compiled and submission ready in a timely manner; prepare FDA Form 2253.
Requirements:
Bachelor’s degree in Biochemistry, Chemistry, Biology, or related science discipline 7 years of relevant experience in pharmaceutical drug development 5 years in regulatory affairs in supporting/coordinating MLR review Demonstrable experience in successfully developing and managing regulatory submissions, Exceptional organizational skills, ability to multi-task and be detail oriented Strong interpersonal and communication (both oral and written) Works well within diverse groups to achieve common goals Ability to maintain highest degree of professionalism, integrity and diplomacy Strong problem-solving skills and ability to deal with changing priorities Excellent project management skills Proficient in pertinent software & tools (Veeva MedComms and Promomats)
Preferred:
Regulatory Affairs Certification through the Regulatory Affairs Professional Society is Prior experience with the preparation of regulatory submissions, as well as knowledgeable with FDA guidelines relevant to advertising and promotion compliance with marketed products Knowledgeable in industry trends for regulatory submission preparation, including electronic document submissions (i.e., eCTD)
California pay range
$150,000—$175,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal, Other, and Writing/Editing Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Arrowhead Pharmaceuticals by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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