Manager, Regulatory Affairs

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Job description

Overview

The Manager, Regulatory Affairs is responsible for defining detailed regulatory strategies and submissions in support of existing marketing authorizations for products at multiple manufacturing facilities. This position ensures timely review of documents, managing submission timelines, and FDA follow up as needed. Additionally, this position will be responsible for supporting labeling activities for marketed injectable products.

Responsibilities

* Develop, communicate and execute regulatory strategies for complex projects including maintenance of licenses/authorizations for existing marketing authorizations. Review and approval of changes controls and documents (batch records, specifications, analytical methods, development reports, protocols, etc.) for regulatory submission and compliance to FDA submission standards.
* Active role in the generation and intradepartmental review of new submissions, supplements, amendments and annual reports. Support resolution of deficiency comments (CRLs and IRs) from the Agency.
* Represent or lead the RA function on assigned cross-functional project teams. Ensure project teams, business objectives and deliverables are aligned with regulatory strategy.
* Monitor applicable regulatory requirements; assure compliance with company and external standards. Provide timely interpretations of applicable Agency guidance documents and support rollout across the organization.
* Establish appropriate communication with the Agency, and relay concise information within RA and other functions, primarily at project level.
* Ensure that labeling is compliant with regulations, and in agreement with Reference Listed Drugs. Will prepare and submit labeling as necessary.
* Develop and document sound regulatory decisions and justifications.
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Qualifications

* BA/BS degree in related scientific discipline with a minimum of 6 years' experience in RA.
* Injectable dosage form and drug labeling experience is prefered and knowledge of device CFR 820 regulations is a plus.
* Sound understanding of U.S. Drug Regulations.
* Strong knowledge of both pre and post approval regulatory submission requirements.
* Understanding of the labeling regulations, including SPL, drug listing, and facility registration requirements.
* Scientific knowledge of the pharmaceutical development and manufacturing processes.
* Ability to manage complex projects and timelines in a matrix team environment.
* Strong oral and written communication and presentation skills.
* Demonstrated interpersonal skills including strong negotiation and collaborative skills.
* Ability to independently identify compliance risks and escalate when necessary.
* Ability to lead and coach others. Will be responsible to mentor and assist in the development of RA staff.

Notification to Agencies

Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.