Sr. Manager, Regulatory Affairs Data Management - Remote

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 
The Senior Manager, Data Management, Regulatory Operations is responsible for the configuration and management of the Regulatory electronic document management system (EDMS) (i.e., Veeva RIMS). This includes management of all regulatory data within the system. The Senior Manager works closely with the Global Regulatory Leads (GRLs) concerning all document and data requirements, ensuring system accuracy.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Data Management
•    Develop and provide department training on data management procedures.
•    Create/update product related master data as requested by GRLs, generate registration related records, generate IDMP or other Agency required data elements, and create data reports as requested.
•    Resolve data integration issues when reported by the GRLs.
•    Support ongoing projects related to Regulatory data.
•    Collaborate with cross-functional teams to provide access to applicable Regulatory data.
•    Develop and expand departmental data governance processes and work cross-functionally to develop an Enterprise data governance process to ensure compliance with Regulatory Agency requirements.
•    Assist in continuous improvement efforts to streamline data processes.
•    Provide updates to the department on relevant regulations and Regulatory Agency guidance related to data requirements (i.e. including but not limited to, FDA, EMA, Health Canada, ICH)

Veeva RIMS System Management
•    Evaluate new configurable functionality and advise Regulatory of proposed improvements. 
•    Configure new changes following Emergent change management procedures (including Veeva Change Management, Global Change Control, and IT Change Management SOPs depending on the level of complexity).
•    Provide departmental training, troubleshoot and resolve customer issues.
•    For complex configurations requiring a Veeva project, lead system projects with IT/VAL/Quality, Veeva support.
•    Participate in Veeva tri-annual release activities with cross-functional departments, create/update and execute validation protocols as required.
•    Perform system annual user audit.
•    Meet regularly with the Veeva Customer Services Manager to coordinate configurations.

Department Responsibilities
•    Work with department leaders and EIM business partners to ensure department metrics are visualized using Power BI.
•    Support department activities to successfully meet submission timelines in a compliant manner including formatting, submission building and linking in the publishing tool and filing through Agency portals.
•    Create/complete Change Controls, Deviations and CAPAs in QMS
•    Create/complete DCCs for creating/revising documents in the Quality EDMS.
•    Create purchase requisitions for the department

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s degree or equivalent is required.
•    7+ years of experience in pharmaceutical industry with 5+ years of experience in regulatory affairs.
•    Experience with Veeva document management is preferred. Experience with other Regulatory Information Management systems will be considered.
•    Experience with computer system configuration and validation protocol testing.
•    Understanding of biological, vaccine, combination product and medical device related data objects.
•    Understanding of regulatory data requirements (i.e., Identification of Medicinal Drug Products (IDMP), etc.) and data governance
•    Technical ability to understand master data, transactional data, data object associations and data flow
•    Ability to anticipate and mitigate potential issues
•    Strong written and verbal communication skills 
•    Strong interpersonal skills.
•    Strong analytical, troubleshooting, and problem-solving abilities
•    Careful attention to detail and accuracy required.
•    Extensive knowledge of MS Word, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat.

# LI-Remote

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $155,500 to $188,200. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.