Regulatory Affairs Associate III

Found in: beBee S IN - 4 weeks ago

Navi Mumbai, India Teva Pharmaceuticals Full time
Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Regulatory Affairs associate III – RA publishing will participate in the publishing of different regulatory activities.  The focus will be to ensure 100% quality and timeline of the submission. Associate must have experience to perform US, EU and Canada submissions This role will be the primary interface with the Regulatory Affairs Associate

How you’ll spend your day
  • Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada. 
  • Exposure in handling initial submissions publishing and transmitting quality submissions to agency.  
  • Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
  • Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions for self as well as peers.  
  • Hands on expertise in EU/US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.          
  • Intermediate to advance understanding of regulatory strategy.
  • Participate in Global Regulatory Affairs project teams and help in implementation of those projects.          
  • Maintain working knowledge of internal and external publishing standards.        
  • Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)       
  • Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz/EURS validator.          
  • Requires minimum guidance while working on day-to-day activities.
  • Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems.    
  • Proactively participate in upcoming projects and provide inputs wherever necessary.       
  • Plan the trainings/knowledge sharing sessions which helps junior team members to understand the process.       
  • Act as Subject matter expert in the team
  • Should have Risk/benefit analysis skills.
  • Capacity to integrate the broad picture as well as detailed analysis.
  • Ability to lead/guide a team in absence of manager.
  • Ability to work under pressure and to tight time deadlines.
Your experience and qualifications
  • B. Pharm/M. Pharm/ Master of Life Sciences
  • Total years of experience required for the role:  6-9 years (preferred - Regulatory Publishing experience in EU and US market)
Knowledge and skills
  • Strategic thinking, strong interpersonal skills including troubleshooting of errors while publishing, strong analytical skills, strong multi-cultural skills, high energy level
  • Proficient in Internal/external communication skills (written & oral) and collaboration (local/regional)
  • Sensitivity to the cultural diversity of a global organization
  • Intermediate to advance level understanding of regulatory IT systems.
Reports To

Manager - Regulatory Submissions Management

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided 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 entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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