Regulatory Consultant

3+ years

Not Disclosed

India

10 April 30, 2025

Job Description

Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Consultant
Updated: March 20, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002289

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.

Why Syneos Health
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 a 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.

Job Summary
Provide regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC), and other lifecycle maintenance activities. Experience in product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams, would be preferred.

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

Author and review Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations, and other lifecycle maintenance activities according to current government regulations and guidelines.
Assess the regulatory impact of change control issued by quality or regulatory department and develop submission strategies.
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, pre-approval submission packages, product registration applications, and post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support agency interactions.
Manage and 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 the 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.
Maintain individual training records (Syneos Health or client-related) and complete all designated required training.

Qualifications
What we’re looking for:

Minimum of 3 years in CMC post-approval variation renewals, annual reports, legal entity name changes, and other lifecycle maintenance activities.
MS, M.Pharm, or PhD degree, preferably in a science-related field, or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device-related experience.
Demonstrated experience in contributing to the preparation of regulatory submissions including, for example, post-approval CMC variations, 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.
Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems would be preferred.
Ability to interact with staff from multiple departments and offices to establish project standards.
Good initiative, adaptability, and pro-activity.
Strong analytical skills and 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.

Get to know Syneos Health
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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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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