Manager - Labeling Job at Amgen (Hyderabad)

Hub Labeling Manager

The Hub Labeling Manager is responsible for preparation of LPDs, associated LLDs...

Location

Chile , Santiago

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs
Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label
Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important

Job Responsibility

To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing
To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval
with a particular focus on digital solutions
To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
To work with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS’s overarching roadmap
To assist with labeling data analysis
To create or enhance SharePoint web pages
The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions
For deliverables in scope, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections

Fulltime

New

Sr. Manager - Global Labeling Compliance

In this crucial role, you will oversee the planning and execution of global labe...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 10 to 12 years of Pharmaceutical, Regulatory, or Quality Management experience
Bachelor’s degree and 12 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience

Job Responsibility

Oversee the planning and execution of global labeling compliance initiatives for our portfolio, working cross-functionally to ensure all labeling activities meet regulatory, quality, and operational standards
Lead a dedicated team of labeling professionals, drive continuous improvement, and serve as a key liaison between regional and global stakeholders
Manage and develop a team of labeling specialists, providing direction, mentorship, and performance feedback
Foster a collaborative environment by guiding cross-functional teams to meet global labeling objectives
Set clear goals and priorities for the labeling team
Oversee end-to-end labeling projects, from content creation and revisions to final implementation
Coordinate across functions and regions to manage complex labeling changes
Develop robust project plans with timelines, milestones, and resources
Ensure alignment with global regulatory requirements and company standards
Implement effective controls for tracking, auditing, and updating labeling content

Labeling Strategist - Manager

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States

Salary:

112744.00 - 152536.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 2 years of related experience
OR Bachelor’s degree and 4 years of related experience
OR Associate’s degree and 8 years of related experience
OR High school diploma / GED and 10 years of related experience

Job Responsibility

Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings
Leads the development and maintenance of core labeling documents including Core Data Sheet (CDS), core patient information leaflet (cPIL), and core instructions for use (cIFU) and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and medication guide
Represents labeling on product-specific global regulatory teams and informs on GRT decisions which impact any relevant portfolio assets
Provides input and leads the strategic guidance to Target Product Labeling
Manages compounds with a medium to high degree of complexity from a labeling perspective
Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategist across the regulatory organization
Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents
Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies
Reviews and provides feedback and approves deviations from core labeling
Ensures deviations from labeling procedures and policies are escalated appropriately

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives

Fulltime

AV Labeling Program Manager II

As a Program Manager with the Physical AI team, you will be responsible for runn...

Location

India , Hyderabad

Salary:

Not provided

Uber

Expiration Date

Until further notice

Requirements

7+ years of experience in program management, data operations, or ML lifecycle management, preferably in a high-growth tech or AI-driven company
Proven success in managing large-scale, high-precision data programs for AI/ML systems
Strong understanding of annotation workflows (LiDAR, image, video) and human-in-the-loop (HITL) model training processes
Experience working cross-functionally with engineering, product, and data science teams
Excellent communication and stakeholder management skills, including experience influencing at senior levels
Hands-on experience working with vendors or third-party data partners, including contracting, onboarding, and performance monitoring
Strong analytical mindset with the ability to turn raw data into actionable insights

Job Responsibility

Lead complex AI/ML programs focused on 2D/3D LiDAR annotations, object detection, semantic segmentation, and other key annotation workflows
Design and implement scalable data pipelines that support model training, quality control, and real-time feedback loops
Partner with engineering and product teams to identify tooling gaps and deliver long-term process and technology improvements
Manage global vendor operations, including RFPs, performance tracking, and quality governance to ensure best-in-class delivery
Develop standard operating procedures (SOPs) for new data initiatives and guide them from pilot phase to full-scale deployment
Use data to drive decisions — analyze program metrics, uncover insights, and present findings to senior leadership to influence product and business strategy
Create and lead cross-functional collaboration frameworks to ensure alignment across stakeholders and smooth execution

Senior Manager, Hub Labeling

Is responsible for executing the content management of LPDs, LLDs and PLDs for n...

Location

Australia , Sydney

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Advanced academic qualifications/degree such as PhD
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs
Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label

Job Responsibility

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions
Acts as a subject matter expert for local labeling throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval
Sharing of intelligence and contribution to knowledge resources is also a key part of the role
The Senior Manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level
The Senior Manager will insightfully seek technology solutions leveraging process automation and Artificial Intelligence (AI)
May lead/manage projects
May supervise/lead colleagues/teams
May act as delegate/deputy for the TLs
To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing

What we offer

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

Fulltime

Manager, Regulatory Global Labeling

This position will be responsible for leading the development, review, and manag...

Location

United States , San Rafael

Salary:

108000.00 - 162000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
2+ years in Regulatory Affairs
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety

Job Responsibility

Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
Ensure appropriate labeling strategies are communicated to project teams
Ensure labeling is compliant with core labeling and local regulations
Ensure labeling is accurate and of the highest quality
Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
Lead the assigned product labeling teams (PLTs) and support labeling positions
Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion

The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (A...

Location

United States , Cambridge

Salary:

130000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline required
advanced degree preferred
8+ years (Manager) 10+ years (Senior Manager) experience in Regulatory Advertising & Promotion
Strong understanding of FDA promotional regulations (FD&C Act, 21 CFR 202.1, OPDP/OC, CBER/CDER)
Hands-on PRC/MLR experience and 2253 submission experience required
Excellent communication, cross-functional collaboration, and regulatory judgment

Job Responsibility

Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling
Manage the lifecycle of core and regional labeling documents including updates, reviews, approvals, and submissions
Ensure claims are truthful, non-misleading, balanced, and aligned with approved labeling and scientific evidence
Prepare and submit FDA Form 2253 filings
maintain records and track OPDP correspondence in conjunction with regulatory operations
Ensure alignment with promotional materials with CCDS, USPI/PI, IFU, and patient labeling
Monitor FDA OPDP/CBER guidance's, enforcement trends, and evolving U.S. regulations
educate internal teams
Support development of SOPs, governance documents, training programs, and inspection readiness activities
Advise cross-functional partners on scientific substantiation, evidence gaps, and claims strategy

Fulltime

Cannabis Budtender

Location

United States , Watertown

Salary:

18.00 - 20.00 USD / Hour

Bud's Goods

Expiration Date

Until further notice

Requirements

All candidates MUST be age 21 or over and successfully complete a background check
Effective in delivering a truly distinctive and hospitable guest experience
A profound understanding of the required procedures to ensure that Bud's Goods & Provisions remains in compliance with all local, Department of Health and Cannabis Control Commission regulations
An enthusiastic self-starter who can prioritize tasks, assist others and achieve maximum efficiency
Skilled in Microsoft Office applications and moderately tech-savvy-to troubleshoot minor issues
Proficient cash handling, math skills and attention to detail
Customer-oriented with outstanding interpersonal and communication skills
Strong community awareness with the ability to connect with a diverse population
Behavior management skills including the ability to remain effective and levelheaded under pressure
Multilingual a Plus

Job Responsibility

Ensure each guest feels comfortable by greeting and checking them in a timely manner and accurately performing transactions through the POS system
Maintain an advanced understanding of all products to dispense cannabis and cannabis products that are tailored to each individual guest
Take time to educate guests on the varieties of cannabis and cannabis-infused products
Actively listen to each guest to provide the highest possible level of service
A passion for, and deep understanding of, cannabis and being a part of a bigger picture to help and care for people
Maintain a clean, safe, and well merchandised store environment
Assist as needed in inventory receiving, management, labeling, packaging, and re-stocking
Dispensing cannabis and cannabis products following strict guidelines to remain in compliance with Cannabis Control Commission regulations at all times
Becoming well-versed in Metrc and in using a point of sale (POS) to complete transactions
Having an advanced expressive knowledge of cannabis and cannabis products and all the different consumption methods and storage requirements of all products on the menu

Fulltime

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Manager - Labeling

Job Description

Job Responsibility

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