Regulatory Documentation Manager

Organization: 
AstraZeneca Pharmaceuticals
Job Location: 
Gaithersburg, MD
Job Description: 

Reporting to the Associate Director/ Group Manager, RDM, the Regulatory Documentation Manager (RDM) is responsible for working with Clinical and Regulatory to build and deliver the Clinical modules for eCTD submissions and monthly investigator updates (routine submissions) to the regulatory authorities (eg, INDs, IND AEs, CTAs, MAAs, NDAs, sNDAs, Patient Safety documents, protocols, and drug shipments.)

RDM staff provide authoring support to Clinical Development staff and ensures all Clinical deliverables are published to agreed standards, often to challenging deadlines given the nature of safety and regulatory reporting requirements.

RDM staff are experts in understanding regulatory authority requirements on technical/format aspects, for delivery of submissions worldwide. It is imperative that all deliverables meet the strict technical standards imposed upon the pharmaceutical industry by FDA, EMEA and other Health Authorities.

Must have an in depth knowledge of relevant systems used for clinical information and submission handling.

Overall Responsibilities

* Technical expert and specialist in Document Management Systems, providing guidance for the user community and ensuring regulatory documentation is retrievable, searchable and timely available.
* As an integrated part of project and submission teams, provide submission management and regulatory documentation publishing expertise.
* Expert in Health Authority standards and requirements, and continuously share knowledge within AstraZeneca.
* Train and support authors globally to ensure technical quality is built into the document authoring process ensuring high standards of all regulatory documentation and submission components.
* Participate and contribute to lessons learned (Study and Submission Teams) and share best practices globally within RDM.

Problem solving

* Utilize the ANGEL advanced search functionality to find relevant regulatory documents and submission life-cycle information to assist with litigation requests.

Impact on Business results

* Monitor and act upon speed and quality standards to drive ongoing efficiencies in the clinical submission management process.
* Act upon identified inefficiencies in up-stream processes.

Communication

* Ability to communicate with senior management within the organisation.

Functional Knowledge

* The role holder requires a good knowledge of Clinical Development and Health Authority requirements to meet the business objectives and ensure compliance with regulatory authorities, quality and technical standards.

Specialist Skills

* Utilize the ANGEL search functionality to find relevant regulatory documents and submission life-cycle information.

Business Knowledge

* The role requires a good working knowledge of the pharmaceutical industry and Clinical Development.
* The role holder will ensure that deliverables adhere to industry standards.

What is the global remit? (how many countries will the role operate in?)

* Own country
* Another country
* 2 or 3 countries at a minimum of 40% of time

Requirements:
Essential

* Expert knowledge of ANGEL/First Doc functionality, policies, procedures and processes.
* University degree or equivalent experience.
* Working experience of information management technologies, electronic publishing and/or have the ability to work in accordance to processes.
* Demonstrated ability to work collaboratively in a team environment as well as independently.
* Demonstrated ability to manage own priorities and goals.
* Good English written and verbal communication skills.

Desirable

* Experience of system administration for a validated application within a regulated environment.
* Knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions.
* Knowledge of AZ submission compilation, publishing, approval information processes, tools and standards.

Key Relationships to reach solutions

Internal (to AZ or team)

* Business users across Regulatory and Clinical
* Counterparts in other functions/business units
* QA/QC
* IS support staff

External (to AZ)

* Not Applicable