Vice President, Head of Regulatory & Safety
Jul 25, 2020 21:38:17 GMT -5
agusta, robbmo, and 2 more like this
Post by itellthefuture777 on Jul 25, 2020 21:38:17 GMT -5
New job posting
www.linkedin.com/jobs/view/1938046695/
At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Position Summary
MannKind Corporation is currently seeking a Vice President, Head of Regulatory & Safety. This position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. This position has the responsibility for tracking trends and requirements in the global market and the impact that the changes will have on the company’s portfolio. They will also be responsible for analyzing and evaluating the company’s regulatory procedures to ensure the attainment of financial and strategic goals. This includes ensuring that all corporate regulatory goals are clearly defined, met, and are in compliance with all current industry standards globally. In addition, this position also serves as the Global Safety Officer with responsibility for managing and overseeing MannKind’s drug safety and pharmacovigilance process. This includes managing compliance with standard operating procedures; regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), and global, regional and country regulations for the reporting of adverse events to regulatory agencies. This role will have oversight of an internal Regulatory & Safety team, be a key member of the R&D leadership team, and requires a candidate with deep knowledge and understanding of the global regulatory environment and a passion for patient care.
Principal Responsibilities
Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture
Identify the need for new regulatory policies, processes, and SOPs
Anticipate global regulatory changes and develops proactive strategies accordingly
Provide strategic guidance to drug development on all aspects of regulatory requirements
Interpret FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders, developing and implementing successful issue resolution strategies.
Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
Develop and plan innovative regulatory strategies for label enhancements and life cycle product management
Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Provide review and approval of all external-facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time
Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
Serve as senior safety officer for pharmacovigilance activities across the portfolio
Provide strategic consultation and guidance on all decisions that have significant drug safety implications
Oversee the preparation of new drug application safety updates (e.g. PSUR), investigational new drug safety reports, investigator communications, and product labeling/package inserts and other reports as necessary.
Manage and conduct ongoing safety surveillance on company products.
Participate in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety.
Establish, maintain, direct and communicate a global benefit-risk strategy for each pre-market, marketed and future MannKind product that includes risk management and minimization
Provide PV contributions in efforts to secure global regulatory approvals
Be accountable for the acquisition, processing, storage, retrieval and distribution of information concerning SAEs in clinical trials
Collaborate closely with Research, Preclinical, Clinical, Regulatory Affairs, and Medical Affairs to ensure tight strategic integration of drug safety plans
Prepare safety information to support licensing partners and contract research organizations, review safety documents prepared by licensing partners and contract organization, and communicate with licensing partners and contract organizations on safety matters per agreements
Responsible for observing all Company, Health, Safety, and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Education And Experience Qualifications
Bachelor’s degree in related field; Ph.D. or PharmD strongly preferred
Minimum of 15 total years of progressive related experience in regulatory affairs and pharmacovigilance in the pharmaceutical/biotech industry
BS/BA and/or Master’s Degree in a scientific discipline or equivalent
Experience with designing and executing creative regulatory strategies for innovative products
Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes
Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial
Experience with clinical trials and regulatory documentation is required
Experience with inhalation products, biologics preferred
Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management
Excellent organizational, written and verbal communications, project and time management skills needed to drive multiple ongoing projects simultaneously
Results-driven and team-oriented with the ability to influence outcomes
Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients
Willing to travel up to 15%
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.
www.linkedin.com/jobs/view/1938046695/
At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Position Summary
MannKind Corporation is currently seeking a Vice President, Head of Regulatory & Safety. This position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. This position has the responsibility for tracking trends and requirements in the global market and the impact that the changes will have on the company’s portfolio. They will also be responsible for analyzing and evaluating the company’s regulatory procedures to ensure the attainment of financial and strategic goals. This includes ensuring that all corporate regulatory goals are clearly defined, met, and are in compliance with all current industry standards globally. In addition, this position also serves as the Global Safety Officer with responsibility for managing and overseeing MannKind’s drug safety and pharmacovigilance process. This includes managing compliance with standard operating procedures; regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), and global, regional and country regulations for the reporting of adverse events to regulatory agencies. This role will have oversight of an internal Regulatory & Safety team, be a key member of the R&D leadership team, and requires a candidate with deep knowledge and understanding of the global regulatory environment and a passion for patient care.
Principal Responsibilities
Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture
Identify the need for new regulatory policies, processes, and SOPs
Anticipate global regulatory changes and develops proactive strategies accordingly
Provide strategic guidance to drug development on all aspects of regulatory requirements
Interpret FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders, developing and implementing successful issue resolution strategies.
Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
Develop and plan innovative regulatory strategies for label enhancements and life cycle product management
Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Provide review and approval of all external-facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time
Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
Serve as senior safety officer for pharmacovigilance activities across the portfolio
Provide strategic consultation and guidance on all decisions that have significant drug safety implications
Oversee the preparation of new drug application safety updates (e.g. PSUR), investigational new drug safety reports, investigator communications, and product labeling/package inserts and other reports as necessary.
Manage and conduct ongoing safety surveillance on company products.
Participate in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety.
Establish, maintain, direct and communicate a global benefit-risk strategy for each pre-market, marketed and future MannKind product that includes risk management and minimization
Provide PV contributions in efforts to secure global regulatory approvals
Be accountable for the acquisition, processing, storage, retrieval and distribution of information concerning SAEs in clinical trials
Collaborate closely with Research, Preclinical, Clinical, Regulatory Affairs, and Medical Affairs to ensure tight strategic integration of drug safety plans
Prepare safety information to support licensing partners and contract research organizations, review safety documents prepared by licensing partners and contract organization, and communicate with licensing partners and contract organizations on safety matters per agreements
Responsible for observing all Company, Health, Safety, and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Education And Experience Qualifications
Bachelor’s degree in related field; Ph.D. or PharmD strongly preferred
Minimum of 15 total years of progressive related experience in regulatory affairs and pharmacovigilance in the pharmaceutical/biotech industry
BS/BA and/or Master’s Degree in a scientific discipline or equivalent
Experience with designing and executing creative regulatory strategies for innovative products
Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes
Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial
Experience with clinical trials and regulatory documentation is required
Experience with inhalation products, biologics preferred
Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management
Excellent organizational, written and verbal communications, project and time management skills needed to drive multiple ongoing projects simultaneously
Results-driven and team-oriented with the ability to influence outcomes
Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients
Willing to travel up to 15%
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.
