Instagram
youtube
Facebook

Regulatory Affairs Associate I

2-5 years
Not Disclosed
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Associate I

Date: May 17, 2024

Location: Bangalore, India, 560064

Company: Teva Pharmaceuticals

Job ID: 55405

About Teva Pharmaceuticals:

Teva Pharmaceuticals is dedicated to making good health more accessible and affordable worldwide. With a presence in nearly 60 countries, we are the leading manufacturer of generic medicines and produce many products on the World Health Organization’s Essential Medicines List. Our mission is to help millions of people enjoy healthier lives through innovative pharmaceutical solutions.

Responsibilities:

  1. Assessment of Change Controls:

    • Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.
  2. Variations Compilation:

    • Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.
  3. Regulatory Database Management:

    • Manage regulatory databases and Trackwise system efficiently.

Experience and Qualifications:

Qualifications:

  • Academic degree with a chemical/pharmaceutical background.

Experience:

  • 2-5 years of experience in CMC Regulatory Affairs, focusing mainly on Europe and International Markets.
  • Proficient in registration procedures and pharmaceutical regulations.
  • Familiarity with Document Management Systems.
  • Strong prioritization skills and ability to adhere to timelines.
  • Capable of working independently with moderate guidance.
  • Problem-solving abilities and implementation of process improvements.
  • Team player mentality.

Reporting Structure:

Reports to Senior Manager – CMC Regulatory Affairs.

Teva’s Equal Employment Opportunity Commitment:

Teva Pharmaceuticals is dedicated to providing equal employment opportunities. We are committed to a diverse and inclusive workplace where individuals are valued regardless of 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 prioritize creating an accessible candidate experience and provide accommodations throughout the recruitment and selection process as needed. All accommodation information is treated confidentially.