Associate Director, Regulatory Affairs CMC
Associate Director, Regulatory Affairs CMC
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$ 199500 - 220500
1 Vacancy
Job Description
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.
Reporting to the Executive Director Regulatory Affairs - CMC the Associate Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.
Responsibilities:
Formulates CMC regulatory strategies with supervisor oversight based on current regulatory intelligence
Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams
Identifies the required documentation and any content quality and timeline issues for global submissions and negotiates the delivery of approved technical documents in accordance with project timelines
Manages the preparation authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications as well as post-marketing variations. May require technical regulatory authoring of submission package components.
Supports the evaluation of manufacturing changes for the potential impact on products
Provides expert review of CMC documentation supporting regulatory submissions and communications
Coordinates preparation of responses to queries from regulatory authorities particularly focused on CMC. May require technical regulatory authoring to support responses to queries
Maintains up to date knowledge and expertise with FDA/EMA regulations ICH guidelines and other international regulatory regulations and guidelines as needed to support global programs
Ensures conformance to commitments made with various regulatory agencies (eg IND/CTA commitments) for assigned programs
Provides regulatory advice to other functional areas
May participate in regulatory due diligence activities
Relationships:
Builds and maintains collaborative relationships with external business partners to achieve project regulatory goals
Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals issues and timelines
Develops and manages relationships with external vendors and regulatory health authorities
Coordinates activities for meetings and conferences with FDA EMA and other regulatory authorities
Collaborates with regulatory colleagues to provide CMC expertise as needed
Management:
This is an Individual Contributor position; however there is the possibility for supervising consultants/contractors and/or interns
Develops and implements regulatory operating guidelines and common work practices/strategies within the team
Qualifications:
10 years of drug development including 5 years of regulatory affairs CMC experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development ; experience in the cardiovascular therapeutic area is a plus
Bachelors degree is required preferably in chemistry or a closely related field; advanced degree is a plus
Excellent working knowledge of international regulatory requirements and environment including an understanding of GXP
Solid working knowledge of core processes: discovery development and manufacturing of small molecules
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
Ability to work effectively across teams functions and with outside partners
Excellent oral and written communication skills
Excellent organizational skills and attention to detail
Pay Range:
In the U.S. the hiring pay range for fully qualified candidates is $199500-$220500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region job-related knowledge skills and experience among other factors.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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain () and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
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If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Director
Employment Type
Full-Time
