Cco - Boston, MA, United States - Apex Systems

Description

Director/Assoc Director Regulatory Affairs
Associate Director/Director, Regulatory Affairs


Location:
Boston, MA(Remote)


Job Overview:

The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendments, and maintenance activities in a collaborative team environment.

Collaborate as the Regulatory lead on project/clinical study teams to provide input on documentation and procedural requirements set by Regulatory Authorities, including submission delivery strategy, document reviews, and analysis of development procedures.

Coordinate regulatory submissions by working with business partners, external experts, CROs, and internal colleagues, and create, review, and edit submissions to support development efforts such as IND submissions and Clinical Trial Applications.

Lead multidisciplinary teams in preparing responses to Regulatory Agency questions during the review phases, and ensure proper planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.

Associate Director/Director, Regulatory Affairs


Location:
Boston, MA(Remote)


Job Overview:

The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendments, and maintenance activities in a collaborative team environment.

Collaborate as the Regulatory lead on project/clinical study teams to provide input on documentation and procedural requirements set by Regulatory Authorities, including submission delivery strategy, document reviews, and analysis of development procedures.

Coordinate regulatory submissions by working with business partners, external experts, CROs, and internal colleagues, and create, review, and edit submissions to support development efforts such as IND submissions and Clinical Trial Applications.

Lead multidisciplinary teams in preparing responses to Regulatory Agency questions during the review phases, and ensure proper planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.

Bachelors, Masters, or PhD degree in a scientific or medical discipline and possess at least 5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or related industry.

Additional Skills, licenses, or certifications in Regulatory Affairs, with Regulatory Affairs Certification (RAC) being highly desirable.

Demonstrated hands-on experience in managing and preparing regulatory submissions, particularly Clinical Trial Applications outside of North America, with a focus on European applications using the Clinical Trials Information System (CTIS).

Exhibit a proven track record of successful clinical trial submissions in Canada, US, and Europe, coupled with a strong competency in understanding global regulatory requirements and evolving regulatory landscape.

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.

PROVEN SCIENTIFIC PLACEMENT

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at .We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.