This job offer is not available in your country.
Sr Manager Regulatory Affairs - US Labeling
Teva PharmaceuticalsBengaluru, Karnataka, India2 days ago
Job descriptionResponsible for establishing and effectively implementing labeling strategies associated with the development and maintenance of labeling for all US generic product ANDAs / 505(b)2s, (pre and post-approval). Assures that all required FDA reporting obligations are met in accordance with established business objective and regulations. Provides guidance and leadership regarding best practices in the labeling arena. Hands on leader in regard to daily workload SME in the development, review, & electronic compilation of labeling documents to align with the RLD, FDA solicited safety changes, company initiatives, & submission requirements for assigned ANDAs / 505(b)(2)s per internal processes & prior to final disposition. Responsible for assigning labeling projects. Oversee the maintenance of the labeling trackers ensuring all assigned projects remain on track. SME in Structured Product Labeling (SPL) ensuring alignment with applicable FDA regulations & guidance’s. Work closely with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling. Work closely with external departments to align with product / device strategy impacting pre and post approval portfolio. Attend meetings relevant to area of responsibility. Create, revise, and / or train on SOPs / WIs, as appropriate. Maintain a metric of all team projects for reporting purposes. Maintain knowledge of US regulations, guidelines, & SOPs / WIs applicable to US Gx labeling. Experience in developing labeling content that requires carve outs due to protected language associated with patent / exclusivities is preferred. Performs all other job related duties as required by management. M Pharm / B Pharm with a Scientific or Regulatory background or equivalent combination of education and experience Total years of experience required for the role : Minimum 8 years of US labeling experience and at least 3 years supervisory experience preferred Relevant years of experience : Minimum 8 years Pharmaceutical industry experience required, specifically in Regulatory Affairs & US ANDA / 505(b)(2) labeling
The Opportunity :
- The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA / 505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any / all team databases and trackers.
- The candidate must possess a firm knowledge of FDA US labeling regulations & guidance for products filed under an ANDA / 505(b)2 and should be a SME in all facets of US labeling, including, but not limited to SPL, PADERs, and AR compilation.
- Finally, candidate will be responsible for ensuring all required FDA reporting obligations are met in accordance with business objectives & regulations maintaining 100% compliance.
Roles & Responsibilities :
Qualification & Experience :
Create a job alert for this search
Sr Manager • Bengaluru, Karnataka, India
Related jobs
)
- Promoted
Content Strategist
Material DepotGreater Bengaluru Area, India Content Strategist @ Material Depot.Location : JP Nagar Phase 3, Bangalore.Material Depot is building the Ultimate Home Decor Destination—redefining how India shops for interiors - tiles, laminates,...Show moreLast updated: 16 days ago
- Promoted
Sr Technical Recruiter- ASIC
Prodapt ASIC services (Formerly Innovative Logic)Greater Bengaluru Area, India Prodapt is a global technology company and the largest specialized player in the Connectedness industry.As an AI-first strategic partner, Prodapt provides consulting, business transformation, and m...Show moreLast updated: 16 days ago
- Promoted
Regulatory Affairs Excellence Specialist
PhilipsBengaluru, Karnataka, India Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organiza...Show moreLast updated: 17 days ago
- Promoted
labeling specialist
Biocon BiologicsBengaluru, Karnataka, India Regulatory Affairs Labeling Specialist role Key Responsibilities : Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) lab...Show moreLast updated: 30+ days ago
- Promoted
Senior Labeling Specialist Trainer – Medical Devices Industry
Tek SupportBengaluru, Karnataka, India Job Title : Senior Labeling Specialist Trainer – Medical Devices Industry Location : Remote Job Type : Part-time Job Summary : We are seeking an experienced Labeling Specialist Trainer with over ...Show moreLast updated: 1 day ago
- Promoted
- New!
Lead - Brand Designer
AdScalarGreater Bengaluru Area, India AdScalar is a data-first advertising growth marketing company that specializes in powering e-commerce D2C unicorns to achieve scalable growth.
The company is committed to delivering a high return on...Show moreLast updated: 5 hours ago
- Promoted
Manager Global Regulatory Affairs
Biocon BiologicsBengaluru, Karnataka, India Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 21 days ago
- Promoted
- New!
Sr Manager Regulatory Affairs - US Labeling (15h Left)
Teva PharmaceuticalsBengaluru, Karnataka, India The Opportunity : - The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affec...Show moreLast updated: 2 hours ago
- Promoted
Senior Business Execution Consultant
Wells FargoBangalore Rural, Karnataka, India Wells Fargo is seeking a Senior Business Execution Consultant.Lead support functions or operations for multiple business groups and contribute to large scale strategic initiatives.Ensure efficiency...Show moreLast updated: 23 days ago
- Promoted
Senior Business Development Manager (North America OR EU)
FreshworksGreater Bengaluru Area, India Generate qualified opportunities for the company by rigorously prospecting and researching in the assigned region / market.
Do rigorous research on assigned accounts, and build an effective sales pipe...Show moreLast updated: 16 days ago
- Promoted
Manager / Senior Manager Business Development
ZestMoneyGreater Bengaluru Area, India Check out financing experience a must!!.ZestMoney’s merchant and partner ecosystem.The Business Development Manager / Senior Manager will act as the bridge between ZestMoney and external stakeholders...Show moreLast updated: 11 days ago
- Promoted
Regional Sales Manager
AwignGreater Bengaluru Area, India Awign is a "work-as-a-service" platform that empowers enterprises to execute diverse work requirements through a network of 1.
We cater to a wide range of enterprise needs, including promoter deploy...Show moreLast updated: 16 days ago
- Promoted
Regulatory Affairs Manager- SME
Mount Talent Consulting Pvt Ltd.Bengaluru, Karnataka, India Domain lead - SME - Safety and Regulatory.Expert in Pharma domain’s multiple functions especially Regulatory and Safety.Well versed with business functions and tools used by industry.Able to create...Show moreLast updated: 2 days ago
- Promoted
- New!
Content Strategist
TurnoGreater Bengaluru Area, India As a Content Strategist, you will lead the development, execution, and management of all content formats, including social media, brand marketing, and performance-driven campaigns.Your role require...Show moreLast updated: 5 hours ago
- Promoted
Assistant Manager SAP FICO
SATRACBangalore Rural, Karnataka, India Cost & Profit Centre Accounting (CPA).SAP S / 4HANA – Cloud Public Edition.S / 4HANA Cloud Public Edition (Financial Accounting).
Testing, Support, and User Training.Business Requirement Gathering.Funct...Show moreLast updated: 2 days ago
- Promoted
Parts Manager
SATRACBangalore Rural, Karnataka, India To manage and oversee spare parts operations across all service locations in India, ensuring timely availability of parts, effective inventory management, vendor coordination, and process optimizat...Show moreLast updated: 2 days ago
- Promoted
Senior Commercial Manager - Performance Materials
CoatsGreater Bengaluru Area, India Senior Manager PM – Commercial (Flame Retardant & Personal Protection).Flame Retardant (FR) and Personal Protection (PP) product lines.
The role focuses on revenue generation (target range : $5–10 mi...Show moreLast updated: 2 days ago
- Promoted
Senior Associate
RSM US LLPGreater Bengaluru Area, India We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their ful...Show moreLast updated: 30+ days ago