Manager/Sr. Manager, Regulatory Affairs - Oklahoma City, United States - HireMinds

Description

Manager/Sr. Manager, Regulatory Affairs

Waltham, MA

Our client is a biopharmaceutical company developing a new generation of oral therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer.

Job Description:

Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc.

Interface with external Regulatory Operations vendor to support submissions to FDA.

Manage, track, and file all required SAE reports to FDA in accordance with Agency guidelines.

Liaise with CRO in the compilation of documents for ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates.

Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.

Participate in cross-functional sub-teams focused on the execution of regulatory strategy.

Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company.

Acquire and manage regulatory intelligence, liaise with regulatory intelligence external vendors (as needed), and communicate information to key stakeholders.

Assist in the setup, management, and maintenance of the regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).

Previous RIMS experience is a plus.


Qualifications:
BS or MS with at least 4 years of direct experience in Regulatory Affairs in the pharmaceutical/biotech industry.

Strong knowledge of FDA regulations is required.

An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is preferred.

Experience in managing the preparation of regulatory documents including individual modules of a new IND, Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format.

Experience with small molecule drug development is preferred.

Experience with early development programs is a plus.

Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.

Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle.

A three-day per week onsite presence is required for effective team interaction.

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