Director, Regulatory Affairs CMC at Cytokinetics

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CardiovascularIndustries

Requirements

10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry
Experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility
Bachelor’s degree is required

Responsibilities

Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence
Collaborate with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represent the department in cross-functional project teams
Identify the required documentation and any content, quality and timeline issues for global submissions and manage the delivery of approved technical documents in accordance with project timelines
Manage 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
Support the evaluation of manufacturing changes for the potential impact on products
Provide expert review of CMC documentation supporting regulatory submissions and communications
Coordinate preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries
Maintain knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
Ensure conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs
Provide regulatory advice to other functional areas
May participate in regulatory due diligence activities
Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals
Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
Develop and manage relationships with external vendors and regulatory health authorities
Coordinate activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Collaborate with regulatory colleagues to provide CMC expertise as needed
This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns
Develop and implement regulatory operating guidelines and common work practices/strategies within the team

Skills

Key technologies and capabilities for this role

CMC Regulatory StrategyRegulatory IntelligenceGlobal SubmissionsCMC DocumentationTechnical AuthoringManufacturing ChangesRisk IdentificationCross-Functional CollaborationClinical Trial ApplicationsMarketing Applications

Questions & Answers

Common questions about this position

What is the salary or compensation for the Director, Regulatory Affairs CMC position?

This information is not specified in the job description.

Is this Director, Regulatory Affairs CMC role remote or does it require office presence?

This information is not specified in the job description.

What key skills and experience are required for the Director, Regulatory Affairs CMC role?

The role requires expertise in formulating CMC regulatory strategies independently, knowledge of FDA/EMA regulations and ICH guidelines, technical regulatory authoring for submissions, and collaboration with cross-functional teams.

What is the company culture like at Cytokinetics?

Cytokinetics seeks tenacious, compassionate, and collaborative individuals who are driven to make a positive impact, with each team member playing an integral part in advancing the mission to improve patients' lives.

What makes a strong candidate for the Director, Regulatory Affairs CMC position?

Strong candidates will have the ability to lead regulatory strategies independently, build collaborative relationships across teams and with external partners, and provide expert regulatory advice on CMC matters for global submissions.

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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