Kinapse

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

Regulatory Manager (CMC Regulatory Affairs)

Updated: August 27, 2021
Location: Gurgaon, HR, India
Job ID: 135056


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Overview

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health
•  SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference. 
•  We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 
•  We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Responsibilities

  • Be a part of the Project management team overseeing successful initiation, execution and completion of Regulatory, CMC or Publishing programs for Kinapse’ Global clients
  • Responsible for process implementation and ensuring process compliance
  • Exhibit skills for program strategy, identification and mitigation of program risk
  • Review and provide solutions for issues relating to program delivery or escalates appropriately to the Program Lead / Program Director as require
  • Proactively identify business development opportunities and internal business development efforts
  • Seek opportunities to increase client satisfaction and deepen client relationships
  • Take a role on contract discussions and negotiations for any assigned programs and brings in the relevant internal parties to ensure a satisfactory conclusion regarding new or extension of contracts
  • Identify and provide standards for gathering information for use in trend analysis and reports information to company management
  • May act as a people development group (PDG) lead
  • May be involved in people development in partnership with PDG leads
  • Provide training and mentoring of team members depending upon the program requirement

Job Requirements

  • Relevant experience in Regulatory affairs CMC with exposure to regulatory filings as a part of a pharmaceutical company.
  • Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems.
  • May be an experienced people manager
  • Significant knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
  • Ability to motivate team members, provide coaching & support development, troubleshooting, tracking deadlines and acting as a primary or second degree reviewer
  • Excellent written communication skills

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.


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