Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Executes global CMC regulatory strategies for post-approval pharmaceutical changes, including product change assessments, health authority responses, regulatory submissions, dossier updates, and technical justifications. Coordinates cross-functional reviews, document sign-off, query and commitment management, risk escalation, and regulatory system maintenance. The role requires applying international regulatory guidelines and managing multiple projects under team-lead guidance.
Top Skills:
DatabasesDocument Management SystemsGdmsWindowsNavigationPdmPublishing ToolsSpaSubmission Management ToolsTrackwise
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports global pharmaceutical regulatory CMC activities for license renewals and annual reports. Authors and compiles CMC dossier contributions, reviews post-approval changes and stability information, applies regulatory guidelines, develops technical justifications, coordinates document reviews, manages commitments and queries, and updates submission components. Collaborates with global regulatory strategists, manufacturing, supply, and cross-functional teams while monitoring timelines, risks, compliance, and submission accuracy.
Top Skills:
GdmsPdmPearlSpa
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports CMC regulatory activities for pharmaceutical license renewals and annual reports across global markets. Responsibilities include authoring and compiling regulatory dossier contributions, reviewing technical and stability information, applying U.S. regulatory guidelines, coordinating document reviews and approvals, updating dossier components, managing timelines and risks, and using Pfizer regulatory systems. Requires postgraduate education in Pharmacy or Science and foundational knowledge of post-approval regulatory requirements.
Top Skills:
GdmsPdmPearlSpa
ROLE SUMMARY
In Pfizer Digital Research & Development, we work with our R&D partners to accelerate drug development and clinical trials through digital products and solutions.
Within Digital R&D, the Veeva Platform & Services function is responsible for defining the strategy and leading the delivery of the Veeva product suite to end users of Veeva products within Digital R&D. This includes the operation, implementation, and integration of Veeva platform solutions that address R&D business processes effectively. Veeva solutions include Regulatory - RIM (Registrations, Submissions, and Publishing), Clinical (CTMS, eTMF, Study Start Up, and Site Connect), and Quality (QMS and Quality Docs).
Your role as Veeva Release Analyst involves working with a team of release managers/operations associates to plan, schedule, and manage software releases for Veeva platform solutions.
To excel in this role, you should have a combination of strong technical background, people management skills, exceptional organizational skills, and the ability to collaborate effectively with cross-functional teams.
ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
In Pfizer Digital Research & Development, we work with our R&D partners to accelerate drug development and clinical trials through digital products and solutions.
Within Digital R&D, the Veeva Platform & Services function is responsible for defining the strategy and leading the delivery of the Veeva product suite to end users of Veeva products within Digital R&D. This includes the operation, implementation, and integration of Veeva platform solutions that address R&D business processes effectively. Veeva solutions include Regulatory - RIM (Registrations, Submissions, and Publishing), Clinical (CTMS, eTMF, Study Start Up, and Site Connect), and Quality (QMS and Quality Docs).
Your role as Veeva Release Analyst involves working with a team of release managers/operations associates to plan, schedule, and manage software releases for Veeva platform solutions.
To excel in this role, you should have a combination of strong technical background, people management skills, exceptional organizational skills, and the ability to collaborate effectively with cross-functional teams.
ROLE RESPONSIBILITIES
- Participate in the planning, execution, and delivery of software releases, ensuring the smooth deployment of products and services to R&D stakeholders.
- Support release activities, including version control, feature branching, code merges, and deployment
- Develop release plans, progress, and status updates to stakeholders
- Manage day-to-day system activities and mitigate risks mitigate risks related to the release process, including addressing potential bottlenecks
- Prepare necessary documentation, release notes, and communication materials for each release
- Participate in post-release activities, such as issue tracking, bug fixes, and customer support
BASIC QUALIFICATIONS
- HS Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+ years of experience in Computer Science, Software Engineering, or a related technical field.
- Service delivery experience, preferably in pharmaceutical industry
- Technical support and operations management experience participating in robust, cost-effective, high-quality services for external and internal customers.
- Participating in cross-functionals teams including business subject matter experts, technical experts and compliance teams for project execution.
- Good knowledge of analytics, quantitative and problem-solving skills to drive decisions for optimized solutioning.
- Knowledge of stakeholder management, facilitation, influencing and negotiation skills.
- Strong working knowledge on MS Tools - Project, Word, PowerPoint, Excel.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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