Regulatory Affairs Associate Ii

4+ years

Not Disclosed

Navi Mumbai

10 July 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Who We Are

At Teva Pharmaceuticals, we are united in our mission to make good health more affordable and accessible, improving the lives of millions globally. Our team spans nearly 60 countries, bringing together a rich tapestry of nationalities and backgrounds. As the world’s leading manufacturer of generic medicines and a proud producer of many products on the World Health Organization’s Essential Medicines List, we impact at least 200 million people daily with our medicines. We are constantly seeking innovative ways to expand our reach and welcome new team members who are eager to make a difference.

The Opportunity

As an RA Associate II, you will be responsible for preparing high-quality US Gx labeling documents filed under an ANDA, ensuring compliance with federal regulations, and adhering to company deadlines. This role requires a strong understanding of FDA US labeling regulations and guidance to effectively apply them in all work outputs.

How You’ll Spend Your Day

Labeling Document Development: Create and refine labeling documents to ensure they align with the Reference Listed Drug. This includes quality control, proofreading, editing, formatting, and coordinating the review and approval process with the US Labeling Team.
Regulatory Submissions: Prepare labeling documents needed for comprehensive responses to the FDA via appropriate filing modes. This involves developing content for labeling, side-by-side comparisons, SPL updates, and other required submission materials.
Quality Assurance: Work with the team to proofread established labeling files for content accuracy, utilizing manual methods or electronic proofreading tools like TVT.
Project Management: Collaborate with the US Regulatory Labeling Team to ensure timely submission of projects such as RLD updates, safety labeling changes, annual reportable changes, and electronic medication guide initiatives, adhering to eCTD requirements.
Regulatory Knowledge Maintenance: Stay updated on US regulations, guidelines, and standard operating procedures related to US Gx labeling.
Team Collaboration: Operate in a team environment with minimal supervision, assisting the Group Leader in assigning and reviewing labeling documents.
Additional Duties: Perform other job-related tasks as required by management.

Your Experience and Qualifications

Education: M.Sc., M.Pharm, B.Pharm, or equivalent combination of education and experience, with a scientific or regulatory background.
Experience: A minimum of 4 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs with a focus on US Gx labeling.
Skills and Knowledge:
- Ability to multitask in a fast-paced environment.
- Excellent oral and written communication skills.
- Strong organizational skills and attention to detail.
- Ability to work independently and in a team environment.
- Knowledge of FDA US regulations and guidance related to US Gx labeling.
- Familiarity with FDA eCTD submission standards and experience applying these to routine labeling submissions.
- Proficiency in PC and Microsoft Office Suite, particularly Microsoft Word.
- Proficiency in Adobe Acrobat Professional is required.
- Familiarity with TVT is preferred.

Reports To

Manager - Regulatory Affairs

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to providing equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status. We are dedicated to fostering a diverse and inclusive workplace. If contacted for a job opportunity, please inform us of any accommodations needed to support you throughout the recruitment and selection process. All information provided will be treated confidentially and used solely to ensure an accessible candidate experience.

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Regulatory Affairs Associate Ii

Job Description

Who We Are

The Opportunity

How You’ll Spend Your Day

Your Experience and Qualifications

Reports To

Teva’s Equal Employment Opportunity Commitment

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