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Regulatory Affairs Associate

0-2 years
Prefered by Company
10 Nov. 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./M.Pharm/B.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 on a mission to make good health more affordable and accessible, helping millions worldwide enjoy healthier lives. Our work unites diverse teams across nearly 60 countries, reflecting a variety of nationalities and backgrounds.

As the world’s leading manufacturer of generic medicines and a producer of numerous products listed on the World Health Organization’s Essential Medicines List, we positively impact the lives of at least 200 million people daily. While this is a remarkable achievement, we are always seeking new ways to make a difference and welcome individuals ready to join us on this journey.


The Opportunity

We are seeking a dedicated professional to lead and proactively manage all regulatory activities associated with the development, registration, and maintenance of Drug Master Files (DMFs), ensuring alignment with international regulatory requirements.


How You’ll Spend Your Day

Lifecycle Management:

  • Support the lifecycle management of APIs (Active Pharmaceutical Ingredients) from a regulatory perspective.
  • Review and approve specifications, analytical controls, and related documentation as needed.

DMF Coordination:

  • Coordinate the preparation and timely submission of DMFs for relevant markets.
  • Conduct high-level gap analyses for DMFs and communicate risks to relevant departments.
  • Oversee the resolution of gaps during the review period.
  • Respond to deficiency letters and manage related activities.

Regulatory Oversight:

  • Evaluate change requests and determine necessary submissions per market to support requested changes.
  • Ensure DMFs are updated according to regulatory requirements for each market.
  • Manage regulatory aspects and tasks related to assigned commercial APIs.

Pre-Launch and Customer Support:

  • Coordinate pre-launch activities from a regulatory perspective.
  • Provide professional support to customers by addressing service requests promptly.

Continuous Improvement:

  • Stay updated on regulatory guidance, SOPs, and work processes.

Your Experience and Qualifications

Core Competencies:

  • Communication Skills: Strong verbal and written communication skills for internal and external audiences.
  • Customer-Centric Approach: Dedicated to delivering high-quality service.
  • Leadership and Teamwork: Effective in leading and collaborating with teams.
  • Organization: Excellent organizational skills and the ability to meet deadlines.
  • Adaptability: Open to learning, self-motivated, and capable of adapting to new challenges.
  • Initiative: Proactive in seeking solutions and opportunities.
  • Attention to Detail: Accurate and meticulous in execution.
  • Time Management: Ability to prioritize and manage tasks effectively.
  • English Proficiency: Fluent in English, both written and spoken, at a professional level.

Education:

  • A high-level degree in a relevant field, such as chemistry, biochemistry, biology, or biotechnology.

Reports To

  • Manager, Regulatory Affairs, RA|IL (TAPI RA)

Already Working @Teva?

Current Teva employees should apply through the internal career site on "Employee Central" for priority consideration. Opportunities exclusive to Teva employees are also listed on this platform.

For assistance with EC access, contact your local HR/IT partner.


Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is an equal opportunity employer. Our global policy ensures equal employment opportunities are provided without regard to age, race, creed, color, religion, gender, sexual orientation, disability, veteran status, or any other legally recognized protected status.

We are committed to fostering a diverse and inclusive workplace. If you require accommodations during the recruitment process, please inform us. All information will remain confidential and be used solely to ensure an accessible candidate experience.

Make a difference with Teva Pharmaceuticals.