Director CMCRiskManager

Cytokinetics is a late-stage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing first-in-class muscle activators next-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.

As a leader in muscle biology the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function contractility.

Responsibilities:

• Formulate regulatory strategies based on current regulatory intelligence.
• Collaborate with cross-functional project teams external business partners to develop regulatory strategies identify regulatory risks; represent the department in cross-functional project teams.
• Identify required documentation manage delivery of approved technical documents in accordance with project timelines.
• Prepare maintain regulatory submission documents pertaining to data for global clinical trial marketing applications post-marketing variations.
• Support evaluation of manufacturing changes for potential impact on products.
• Provide expert review of CMC documentation supporting regulatory submissions communications.
• Coordinate preparation of responses to queries from regulatory authorities particularly focused on CMC.
• Maintain knowledge expertise with FDA EMA regulations ICH guidelines international regulatory regulations guidelines.
• Ensure conformance to commitments made with various regulatory agencies for assigned programs.
• Provide regulatory advice to other functional areas.
• Participate in regulatory due diligence activities.

Relationships:

• Build maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develop maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals issues timelines.
• Develop manage relationships with external vendors regulatory health authorities.
• Coordinate activities for meetings conferences with regulatory authorities.
• Collaborate 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 interns.
• Develop implement regulatory operating guidelines common work practices/strategies within the team.

Qualifications:

• 10-12+ years related work experience including 8+ years Regulatory Affairs CMC Biotech/Pharmaceutical industry; experience small molecule drug development required experience cardiovascular therapeutic area plus.
• Proven experience serving primary RA-CMC contact Health Authorities full strategic responsibility.
• Bachelor's degree required preferably chemistry closely related field advanced degree plus.
• Excellent working knowledge international regulatory requirements environment including understanding GXP.
• Solid working knowledge core processes associated discovery development manufacturing small molecules.
• Experience eCTD requirements electronic submissions.
• Experience international regulatory submissions processes strong plus.
• Ability work effectively across teams functions outside partners.
• Excellent oral written communication skills.
• Excellent organizational skills attention detail.