24 days old

Hub Submission Manager

Warsaw, IN 46580
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The Hub Submission Manager is accountable for operational management of regional and/or national regulatory dossiers to designated Health Authorities (HA's)

Based within GRA Submission Management, this role sits within a team working to tight, business critical deadlines within a highly regulated environment. Primary focus is on allocated region/countries, with additional responsibility to support other locations through utilization of global tools.

On behalf of Global Regulatory Affairs (GRA), lead and manage logistical and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers - initial application and subsequent lifecycle updates (compliance and maintenance).

Execute, through use of standards and tools, designated operational tasks e.g. submission planning, document receipt, translation management, technical build and submittal to HA or via the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.

Given the scope of international work, critical features of this role are the ability to successfully interface with multiple cultures and, to recognize and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.

The HSM may be assigned as a Global Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected portfolio segment.

**Primary Responsibilities**

+ Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor

+ Engages Submission leaders, business suppliers and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.

+ Leads the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.

+ Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department

+ Provides guidance to and leads moderately complex submission and process improvement projects, making decisions independently

+ Considered a technical resource within the group

+ Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the group toward its goals

**Qualification and Technical Skill Requirements**

+ B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.

+ Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

+ Multi-lingual skills desirable.

+ Familiarity with pharmaceutical organizational structures, systems, and culture is preferred

+ Ability to work on multiple highly complex projects simultaneously.

+ Strong knowledge of the drug development process, regulatory affairs, and submissions management.

+ In depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.

+ Ability to operate seamlessly and influence/mentor direct and indirect reports, as well as across organizations.


**Breakthroughs that change patients' lives** ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.


We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Regulatory Affairs

Posted: 2021-03-29 Expires: 2021-04-29
Sponsored by:
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Hub Submission Manager

Warsaw, IN 46580

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