Add office photos
All Filters
63 Syneos Health Jobs
Senior Regulatory Consultant (EU Market experience)
5-10 years
₹ 8 - 14L/yr (AmbitionBox estimate)
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Senior Regulatory Consultant (EU Market experience)
Syneos Health
posted 2d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
WORK HERE MATTERS EVERYWHERE
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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.
- Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
- Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
- Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
- Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
- Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
- Ensure compliance with appropriate global regulatory requirements and the company s policies and processes.
- Prepare training materials and share best practices in the regulatory area, both internally and externally.
- Participate as regulatory support in internal or external project audits.
- Participate as regulatory support on internal cross-functional initiatives.
- Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
- Provide support in oversight to team members in the execution of their project responsibilities.
- Capable of identifying when to ensure line support required to provide additional guidance and direction.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
- Looking for min 5yrs of experience in CMC authoring and reviewing (specifically Module 3).
- Must have EU market experience.
- BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
- Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
- Excellent interpersonal / communication skills including excellent written and verbal communication skills.
- Excellent customer service skills, with the ability to work both as a team member and independently.
- Good quality management skills.
- Advanced skills in Microsoft Office Applications.
- Ability to interact with staff from multiple departments and offices to establish project standards.
- Good initiative, adaptability, and pro-activity.
- Strong analytical skills, good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Employment Type: Full Time, Permanent
Read full job descriptionSyneos Health Interview Questions & Tips
Prepare for Syneos Health roles with real interview advice
What people at Syneos Health are saying
Rating based on 2 Regulatory Consultant
reviews
Anonymous · Research & Development
Syneos has good benefit and the work culture is incredible here. Managers are extremely supportive and doesn't micro manage and takes care about employee work life balance.
- Salary - Good+6 more
Nothing as such as of now
Regulatory Consultant salary at Syneos Health
What Syneos Health employees are saying about work life
Syneos Health Benefits
Financial Health Learning, Development and Growth Physical Health Employee Resources 
Compare Syneos Health with
IQVIA
Parexel International
ICON Plc
Fortrea Development India Private Limited
PPD
WuXi AppTec
Lambda Therapeutic Research
Aragen Life Sciences
Syngene International
Navitas Life Sciences
SAI Life Sciences
Veeda Clinical Research
Cytel Statistical Software & Services
Cliantha Research
Perceptive
Waters Corporation
Reliance Life Sciences
Spc Life Sciences
Aizant Drug Research Solutions
Accutest Research Laboratories
Senior Regulatory Consultant (EU Market experience)
5-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
Principal Stat Programmer (ADAM, TLFs , SDTM)
11-12 Yrs
Kolkata, Mumbai, New Delhi +4 more
Principal Stat Programmer (ADAM, TLFs , SDTM)
11-12 Yrs
Kolkata, Mumbai, New Delhi +4 more
Sr Medical Writer - (Process Mapping , Scientific Writer)
1-4 Yrs
Kolkata, Mumbai, New Delhi +4 more
Stat Programmer II / Sr Stat Programmer / Prin Stat Programmer
2-6 Yrs
Kolkata, Mumbai, New Delhi +4 more
Sr Medical Writer - (CSR, ICF) Regulatory
2-5 Yrs
Kolkata, Mumbai, New Delhi +4 more
