Cytokinetics
Senior Manager, Regulatory Affairs
Cytokinetics, South San Francisco, California, us, 94083
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
Reporting to the Associate Director, Regulatory Affairs, the Senior Manager of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.
Responsibilities
Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligenceCollaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risksManage coordination, preparation, and timely submission of regulatory documents and filingsReview global regulatory submissions for consistency and quality across regionsManage preparation of responses to queries from regulatory authoritiesMaintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programsEnsure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programsProvide regulatory advice to other functional areasParticipate in regulatory due diligence activitiesRelationships
Build and maintain collaborative relationships with external business partners to achieve project regulatory goalsDevelop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelinesDevelop and manage relationships with external vendors and regulatory health authoritiesManage activities for meetings and conferences with FDA, EMA, and other regulatory authoritiesManagement
May supervise employees, consultants/contractors and interns in Regulatory AffairsDevelop and implement regulatory operating guidelines and common work practices/strategies within the teamOur employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plusExcellent working knowledge of international regulatory requirements and environment, including an understanding of GXPDemonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissionsSolid working knowledge of core processes: discovery, development, and manufacturing of small moleculesExperience with eCTD requirements and electronic submissionsExperience with international regulatory submissions and processes is a strong plusAbility to work effectively across teams, functions and with outside partnersExcellent oral and written communication skillsExcellent organizational skills and attention to detail
Salary pay range: $165000 - $175000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$165,000-$175,000 USD
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
Reporting to the Associate Director, Regulatory Affairs, the Senior Manager of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.
Responsibilities
Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligenceCollaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risksManage coordination, preparation, and timely submission of regulatory documents and filingsReview global regulatory submissions for consistency and quality across regionsManage preparation of responses to queries from regulatory authoritiesMaintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programsEnsure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programsProvide regulatory advice to other functional areasParticipate in regulatory due diligence activitiesRelationships
Build and maintain collaborative relationships with external business partners to achieve project regulatory goalsDevelop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelinesDevelop and manage relationships with external vendors and regulatory health authoritiesManage activities for meetings and conferences with FDA, EMA, and other regulatory authoritiesManagement
May supervise employees, consultants/contractors and interns in Regulatory AffairsDevelop and implement regulatory operating guidelines and common work practices/strategies within the teamOur employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plusExcellent working knowledge of international regulatory requirements and environment, including an understanding of GXPDemonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissionsSolid working knowledge of core processes: discovery, development, and manufacturing of small moleculesExperience with eCTD requirements and electronic submissionsExperience with international regulatory submissions and processes is a strong plusAbility to work effectively across teams, functions and with outside partnersExcellent oral and written communication skillsExcellent organizational skills and attention to detail
Salary pay range: $165000 - $175000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$165,000-$175,000 USD
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer