Sr Manager Regulatory Affairs - US Labeling Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

bengaluru, karnataka, india

On-site

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 ...

Posted 3 weeks ago

AI Match Score

Apply

Regulatory Affairs Associate I, Labeling Teva Pharmaceuticals

1.0 - 5.0 years

0 Lacs

navi mumbai, maharashtra

On-site

Role Overview: As a RA Associate I at the company, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations and meet deadlines to align with company goals. Your role will involve developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring alignment with company goals and submission requirements while meeting all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents. - Establish SPL for assig...

Posted 4 weeks ago

AI Match Score

Apply

Regulatory Affairs Associate II, Labeling Teva Pharmaceuticals

3.0 - 7.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a Regulatory Affairs Associate II, Labeling at Teva Pharmaceuticals, you will play a crucial role in preparing and revising high-quality US Gx labeling documents for submission under an ANDA and/or 505(b)(2). Your responsibilities will include ensuring compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. You will be expected to work with minimal supervision and demonstrate a thorough understanding of US FDA labeling regulations and guidance documents. Your tasks will involve creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance r...

Posted 2 months ago

AI Match Score

Apply

Regulatory Affairs Associate III Teva Pharmaceuticals

6.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide gu...

Posted 2 months ago

AI Match Score

Apply

Regulatory Affairs Manager Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

The Opportunity: The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required. The candidate must possess a firm knowledge of FDA...

Posted 3 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.