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Mgr, Reg Affairs (R1056103) in Thane, India at IQVIA™

Date Posted: 1/9/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Thane, India
  • Experience:
    Not Specified
  • Date Posted:
    1/9/2019
  • Job ID:
    R1056103

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

RESPONSIBILITIES:

Acts as CMC lead/specialist for client projects, will have CMC responsibility for a portfolio of products. 

  • Prepares and reviews CMC documentation required to support worldwide submissions for clinical and commercialized products (small molecules and biologicals) e.g. IMPD’s, MAA’s, post approval variations, facility registrations and renewals;
  • Authors and reviews supportive Module 1, 2 and Module 3 documentation;
  • Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload;
  • Communicates daily with client stakeholders located worldwide, by phone, mail or skype;
  • Actively participates in project teams with internal and external customers and communicates confidently in straightforward matters;
  • May act as a mentor to junior colleagues;
  • Performs other tasks or assignments, as delegated by Regulatory management;
  • May act as Project Manager/CMC RA Lead on different type of projects.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

Technical Skills

  • Bachelor of Science Degree in life science related discipline;
  • 2 to 7 years regulatory CMC experience on marketed products and/or products in development phase, in Europe and/or emerging markets;
  • Knowledge of variations/renewals/procedures in Europe and/or emerging markets;
  • Complete understanding of the content and typical level of detail in Module 3; 
  • Experience in document management systems and other relevant regulatory systems such as regulatory tracking systems and eCTD viewer;
  • Excellent computer skills e.g. Word, Excel;
  • Preparation of appropriate justifications/statements to support variations, MAA’s, renewals etc;
  • Manage cross functional interactions to support CMC activities;
  • Project Management skills: may manage medium to small size projects;
  • Experience in product development/manufacturing or analytical work is a plus.

Soft Skills

  • Excellent time management skills and able to independently manage own workload;
  • Ability to work to tight timelines;
  • Analytical mindset, problem solver and ‘outside-of-the-box’ thinker;
  • Flexible mindset, adaptable to change;
  • Positive attitude and eager to learn;
  • Attention to detail and quality of work;
  • Excellent English verbal and written communication skills;
  • Excellent team player;
  • Cultural awareness; able to communicate with clients and internal colleagues with different cultural backgrounds and in different time zones.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1056103