Eikon Therapeutics, Inc.
Associate Director, Regulatory Affairs
Eikon Therapeutics, Inc., Jersey City, New Jersey, United States, 07390
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform enables real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in the Jersey City, New Jersey, office to ensure effective management, operational excellence and collaboration with the cross-functional teams. About You
The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of ex-US regulatory requirements and guidelines, coupled with exceptional project management, coordination and communication skills. Their proven ability to thrive in a fluid, fast-paced, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, efficient execution, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing global CTA submission strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with programs. What You’ll Do
Global Clinical Trial Application (CTA) Submission Strategy: Develop and execute comprehensive regulatory CTA submission strategies that support clinical trial initiations ex-US and related activities, while aligning with the company’s strategic objectives. Provide advisory to and work with cross-functional teams on developing responses to health authority questions.
International Regulatory Compliance: Advise and stay abreast of evolving ex-US regulations, guidelines, and industry best practices. Ensure that the company’s activities and products adhere to all applicable regulatory requirements. Maintain detailed knowledge of regulations such as EU-CTR (Regulation EU No 536/2014), ICH, and country-specific regulations.
Submission Management: Develop and coordinate the preparation, review, and submission of submission packages and regulatory documents for countries including in Europe, the UK, Norway, Switzerland, Iceland, Latin America, Asia Pacific, and rest of the world (ROW). Develop ex-US dossier content plans in coordination with cross-functional teams. Maintain international CTA lifecycles.
Cross-Functional Collaboration: Collaborate with Study Start-Up (SSU), Clinical Operations Study Management, Clinical Supply Chain, CMC, and other teams to provide regulatory guidance and ensure integration of regulatory considerations into product development.
Communication with Regulatory Agencies: Act as a liaison with regulatory agencies, fostering effective communication and negotiation regarding submissions and inquiries.
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with GCP and GDPR.
Identify and assess regulatory risks and proactively propose solutions to mitigate these risks. Qualifications
10+ years of relevant experience with a Bachelor's degree, or 8+ years with a postgraduate degree, in a relevant scientific discipline preferred In-depth knowledge of international regulatory requirements and guidelines. Ability to interface with submission platforms such as Clinical Trials Information System (CTIS) and Integrated Regulatory Information System (IRIS). Familiarity with study and GMP documentation required by Health Authorities. Exceptional communication, negotiation, and project management skills. Proven ability to thrive in a collaborative, cross-functional team environment. Strong analytical skills, attention to detail, and effective problem-solving abilities. Adaptability and the ability to excel in a fast-paced, high-growth environment. Proficient computer skills and strong electronic technical aptitude. Working knowledge of Veeva, Microsoft Office (Word, Excel, PowerPoint, Project) and Windows. Compensation and Benefits At Eikon, employee compensation includes bonus and equity, in addition to several generous benefits: 401k plan with company matching Medical, dental, and vision insurance (premiums covered by Eikon) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon) and optional supplemental policies Enhanced parental leave Daily subsidized lunch program when on-site The expected salary range for this role is $178,000 to $194,750 depending on skills, competency, and market demand. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
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We are seeking an experienced Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in the Jersey City, New Jersey, office to ensure effective management, operational excellence and collaboration with the cross-functional teams. About You
The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of ex-US regulatory requirements and guidelines, coupled with exceptional project management, coordination and communication skills. Their proven ability to thrive in a fluid, fast-paced, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, efficient execution, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing global CTA submission strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with programs. What You’ll Do
Global Clinical Trial Application (CTA) Submission Strategy: Develop and execute comprehensive regulatory CTA submission strategies that support clinical trial initiations ex-US and related activities, while aligning with the company’s strategic objectives. Provide advisory to and work with cross-functional teams on developing responses to health authority questions.
International Regulatory Compliance: Advise and stay abreast of evolving ex-US regulations, guidelines, and industry best practices. Ensure that the company’s activities and products adhere to all applicable regulatory requirements. Maintain detailed knowledge of regulations such as EU-CTR (Regulation EU No 536/2014), ICH, and country-specific regulations.
Submission Management: Develop and coordinate the preparation, review, and submission of submission packages and regulatory documents for countries including in Europe, the UK, Norway, Switzerland, Iceland, Latin America, Asia Pacific, and rest of the world (ROW). Develop ex-US dossier content plans in coordination with cross-functional teams. Maintain international CTA lifecycles.
Cross-Functional Collaboration: Collaborate with Study Start-Up (SSU), Clinical Operations Study Management, Clinical Supply Chain, CMC, and other teams to provide regulatory guidance and ensure integration of regulatory considerations into product development.
Communication with Regulatory Agencies: Act as a liaison with regulatory agencies, fostering effective communication and negotiation regarding submissions and inquiries.
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with GCP and GDPR.
Identify and assess regulatory risks and proactively propose solutions to mitigate these risks. Qualifications
10+ years of relevant experience with a Bachelor's degree, or 8+ years with a postgraduate degree, in a relevant scientific discipline preferred In-depth knowledge of international regulatory requirements and guidelines. Ability to interface with submission platforms such as Clinical Trials Information System (CTIS) and Integrated Regulatory Information System (IRIS). Familiarity with study and GMP documentation required by Health Authorities. Exceptional communication, negotiation, and project management skills. Proven ability to thrive in a collaborative, cross-functional team environment. Strong analytical skills, attention to detail, and effective problem-solving abilities. Adaptability and the ability to excel in a fast-paced, high-growth environment. Proficient computer skills and strong electronic technical aptitude. Working knowledge of Veeva, Microsoft Office (Word, Excel, PowerPoint, Project) and Windows. Compensation and Benefits At Eikon, employee compensation includes bonus and equity, in addition to several generous benefits: 401k plan with company matching Medical, dental, and vision insurance (premiums covered by Eikon) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon) and optional supplemental policies Enhanced parental leave Daily subsidized lunch program when on-site The expected salary range for this role is $178,000 to $194,750 depending on skills, competency, and market demand. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
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