Search Results: 10 vacancies
...submissions and ensure effective data presentation and quality through effective review.
Responsible for authoring quality and timely CMC contributions for license maintenance activities such as US Annual Reports, Renewals, APRR, YBPR, In-house submission (Brazil) and BPDR...
Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory...
Job Responsibilities :
Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
Responsible for the ...
Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention...
Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross Functional Teams to prepare and submit the variations for entity name change across global markets including US, EU & ROW as per defined timelines. Also responsible...
Functions as a Global Regulatory Lead for the assigned, low to moderately complex products, and/or supports Global Regulatory Lead.
Responsible for/supports developing global regulatory strategies, preparing and submitting the marketing authorization dossier for drug products...
...Requirement
Primary Skill -- Business Object 4.2 (Developer and Administrator), Web Intelligence / Crystal Reports, Universe design, CMC, CMS and Oracle PL/SQL
Secondary Skill -- Windows, Unix scripts, Agile methodology
Jd
Experience 6 to 9 years
To...
...the time.
Working with global scientists and engineers, may perform technical authoring of internal memos and reports and specific CMC sections of regulatory documents using templates and technical reports.
Identify gaps in regulatory documentation readiness and work...
...Has fundamental understanding of XEVMPD, IDMP and other structured data requirements, regulations and telematic projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc)
Uses technical skills to ensure compliance with regulatory obligations including XEVMPD and IDMP
Ability...
...development and above is mandatory)- Strong knowledge of writing SQL/PLSQL and indexing Minimal Configuration and Administration using CMC - Understanding of HANA view and promotion management - Good to have SAP BOBJ Rest SDK Enterprise SDK integration experience - Function...
