Regulatory Consultant -CMC
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
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Job ID 7283
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Career Level Executive
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Experience 2 Years
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Gender MaleFemale
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Category / Function Management
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Qualifications Degree Bachelor
Job Description
Description
Regulatory Consultant
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.
- #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.
Roles and Responsibilities
JOB SUMMARY
Provide regulatory and technical support for assigned product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams.
Skills required :
- Minimum 7 years of experience in writing Module 3 (CMC)
- Must have experience of EU (CMC Authoring-Module 3)
- Good to have US, Australia,Canada, Japan,China, Brazil market (CMC authoring)
- Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
- Good understanding of manufacturing and all aspects related to product development
- Ability to motivate fellow team members, provide troubleshooting, tracking deadlines and potential to act as a first- or second-degree reviewer
- Excellent Communication skills
- Effective management of individual workload; Analytical capabilities, familiarity and comfort with regulatory concepts; Professional service mentality.
Location:
Gurgaon/Bangalore /Hyderabad/Homebased
Qualifications
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.