Job Location

Schwalbach Am Taunus

Job Description

YOUR ROLE

A Global Regulatory Operations Manager in P&G Personal Healthcare (PHC) maintains regulatory data systems like Veeva Vault RIM & PASS and troubleshoots systems issues e.g., (publishing issues). This role ensures electronic submission compliance of documents included in regulatory submissions. The role also involves providing strategic leadership by developing compliance strategies, implementing data governance, and driving process improvements in systems Globally, and specifically for this role in Asia, Middle East & Africa (AMA).

Responsibilities:

Drive process improvement, dossier management and data governance globally.

Contribute to data-driven decision making by leading the interpretation and analysis of data from various sources (reporting capabilities).

Identify and develop automation opportunities and systems improvements.

Explore and enhance opportunities for digitization of RM data/information.  

Support the definition of data entry guidance and system functionalities.

Lead the coordination of market clearances in PASS while collaborating with Regulatory Affairs colleagues and submission team members to define the necessary metadata for updating Veeva RIM records and ensuring effective integration.

Drive the troubleshooting of systems and applications based on their technical proficiency.

Provide document management support, as needed, to facilitate timely delivery of electronic submission ready documents.

Manage user roles, permissions, and access controls to ensure compliance with company policies while championing data verification and promoting data literacy among users in Veeva RIM and PASS

Analyze business processes and end-user needs to design packaged systems with accurate impact assessments, custom programs, front-end applications, and integrations that meet optimal solutions.

Job Qualifications

YOUR PROFILE

Degree in Life-Science (Pharmacy, Medicine, Chemistry, Biology).

Previous proven experience in Regulatory Affairs or Regulatory Operations role preferably in consumer health and across multiple regulatory classification areas (supplements, medicines, medical devices, etc.).

Experience with eCTD and non-eCTD electronic submission authoring and publishing.

Experience in a highly regulated scientific environment, interacting with and interpreting various laws and regulations globally (Human Safety/R&D/Quality).

Technical understanding of Veeva RIM and PASS, along with the ability to troubleshoot technical issues related to their market clearances.

Strong ability to use and manage information management systems.

Solid understanding of submission/publishing processes and requirements, templates, and recommended procedures.

In depth understanding of CTD structure and CTD-eCTD documentation requirements Modules 2 through 5.

Exceptional interpersonal skills and operational understanding by effectively leading global project teams, showcasing strong organizational abilities, and proficiently leading and implementing regulatory affairs projects.

Critical thinking and risk mitigation by understanding business needs and developing strategic solutions, while excelling in communication and stakeholder management within multidisciplinary and multicultural teams.

Proficiency in English, with excellent writing and speaking abilities.

Ability to understand and communicate in German.

WHAT WE OFFER

Exciting work and responsibility from Day 1!

Competitive Compensation, yearly performance-based compensation reviews and an annual bonus from your first year on.

A permanent employment contract in a crisis-resistant market.

Wide range of social benefits: flexible & hybrid work arrangements, Christmas & vacation bonus, company pension plan, stock purchasing programs, job ticket, campus canteen & services such as fitness center, well-being program etc.

Opportunity to engage in our various employee programs: WeBelong Team & New Hire Network activities, GABLE Network & other affinity groups, Inspirational Leadership Events, Sports groups for running & football etc.

Collaborate & lead multi-functional teams with international spirit, work with colleagues across regions and all levels.

APPLICATION

To optimally prepare for our online assessment & interviews, make sure you fully understand our assessment process our application process.

CV in English as a separate document

Cover letter for the specific role you are applying for (optional)

Copy of university diploma and transcript

Copy of relevant work, internship and volunteering certificates or reference letters

Please upload all documents in the "CV/Resume" field. Incomplete applications may lead to delays in the recruitment process.

AT P&G #WESEEEQUAL

We are an equal opportunity employer and value diversity at our company. At P&G, we strive to build a culture where everyone feels welcome, included, and able to bring their full selves to work.

We ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process. Please click here if you require accommodation during the application process and please make sure to wait to hear back from us regarding your accommodation before proceeding with the online assessment. We thank you in advance for your patience.

Job Schedule

Full time

Job Number

R000120504

Job Segmentation

Experienced Professionals (Job Segmentation)