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Reg Affairs Officer 2 - (1805900) in Mumbai, IN at IQVIA™

Date Posted: 4/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Mumbai, IN
  • Job Type:
    Regulatory
  • Experience:
    At least 3 year(s)
  • Date Posted:
    4/14/2018
  • Job ID:
    1805900

Job Description

At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.

PURPOSE

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.

RESPONSIBILITIES

• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.

• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.

• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.

• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.

• May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.

• May act as reviewer for regulatory SOPs, as assigned and appropriate.

• May prepare and deliver regulatory training to Quintiles small groups or individuals.

• Performs other tasks or assignments, as delegated by Regulatory management.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Possesses a specific regulatory or technical expertise

Good, solid interpersonal communication (oral and written) and organisation skills

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

Demonstrates negotiation skills and is confident in making decisions with minimal supervision

Ability to work on several projects, retaining quality and timelines

Ability to follow SOPs consistently; provides independent thought to assist in process improvements



Job Requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 7-9 years experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Travel will be required


Connect to great opportunity™


Quintiles is a strong advocate of diversity and inclusion in the workplace.  We believe that a work environment that embraces diversity will give us a competitive


advantage in the global marketplace and enhance our success.  We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees


builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.


• Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute

Job ID: 1805900