Position We are seeking an experienced Associate Director, Clinical Regulatory, 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, coordinating and communication skills. Their proven ability to thrive in a fluid, fast-paced collaborative, 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, 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), International Conference on Harmonization (ICH), and country-specific regulations.
- Submission Management:
- Develop and coordinate on the preparation, review, and submission of submission packages and regulatory documents for countries such as in Europe (European Union [Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic (Czechia), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden], other European countries, UK, Norway, Switzerland, Iceland), Latin America, Asia Pacific (including Australia, New Zealand, China, South Korea), 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 closely with Study Start-Up (SSU), Clinical Operations Study Management, Clinical Supply Chain, CMC, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process.
- 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 Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR).
- Risk Assessment:
- Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.
Qualifications- 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree, in a relevant scientific discipline preferred
- In-depth knowledge of international regulatory requirements and guidelines.
- Ability to interface well with submission platforms such as Clinical Trials Information System (CTIS), or Integrated Regulatory Information System (IRIS).
- Familiarity also 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, strong electronic technical aptitude.
- Working knowledge of Veeva, Microsoft Office (including Word, Excel, PowerPoint, Project) and Windows.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- 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 at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $178,000 to $215,250 depending on skills, competency, and the market demand for your expertise.
