Manager/Sr. Manager, Regulatory Affairs

4 weeks ago

Watertown, United States Planet Pharma Full time

Job Description:

The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines.

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).

Essential Job Functions:

Excellent people skills, and experience developing strategic, and long-term relationships with key stakeholders.

Strong organizational, problem-solving, and analytical skills, as well as the ability to multi-task.

Demonstrated ability to clearly communicate the status of work, issues that arise, and proposed solutions to challenges to manager, team members, and head of the department.

Attention to detail and the ability to work individually, within a multidisciplinary team, and with external parties.

Strong team player who has a customer service approach and is solution oriented.

Ability to work in a fast-paced environment and meet aggressive timelines.

Strong written and verbal communication skills, including some regulatory writing experience.

Advanced knowledge of the Microsoft suite of tools including Word, Adobe, PowerPoint, Excel is required.

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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