Regulatory Consultant

Syneos Health; Gurugram District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Syneos Health is seeking a Regulatory Consultant with extensive experience in regulatory affairs, focusing on EU markets. The ideal candidate has a Masters degree in a science-related field and at least 4-5 years of expertise in CMC modules and regulatory submissions.

Key responsibilities include conducting research for regulatory requirements, preparing submissions for regulatory agencies, and providing support in day-to-day regulatory activities. Excellent communication and interpersonal skills are crucial for this role.

Qualifications

• Minimum 4-5 years of experience in regulatory affairs.
• Experience in CMC module 3 and authoring CMC sections.
• Moderate pharmaceutical/medical device related experience.
• Demonstrated experience in regulatory submissions including IND, PMA, NDA, MAA, and CTD.

Responsibilities

• Conduct research on existing product data for regulatory requirements.
• Prepare technical components of regulatory agency submissions.
• Manage day-to-day regulatory activities for assigned projects.
• Act as a subject matter expert and assist team members.
• Ensure compliance with global regulatory requirements.

Skills

Interpersonal skills

Communication skills

Quality management skills

Analytical skills

Adaptability

Microsoft Office Applications

Education

Masters degree in a science-related field

Job description

Regulatory Consultant (EU mkt, Module 3)

Job Responsibilities

• Should have min 4-5 yrs of experience in regulatory affairs
• Should have Mpharm degree
• Should have experience of CMC module 3, authoring of CMC sections of Post Approval variations and life cycle management activities
• Should have in EU, GCC mkt experience

For non-complex and complex submissions, independently fulfill the following responsibilities:

• 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‑to‑day regulatory activities for assigned projects 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 team members with day‑to‑day troubleshooting 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

Qualification Requirements

• Masters 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 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