Regulatory Consultant

3+ years

Not Disclosed

India

10 March 24, 2025

Job Description

Job Type: Full Time Education: M.Pharm/PhD/MS 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
Regulatory Consultant

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 we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and for. Whether joining us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

Why Syneos Health:

Focus on career development and progression.
Supportive and engaged line management.
Technical and therapeutic area training with peer recognition and total rewards programs.
Dedicated to creating an inclusive culture that promotes diversity of thought, background, and perspective.

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, is preferred.

Job Responsibilities:

Author and review Module 3 CMC sections for post-approval variations, renewals, and annual reports according to current regulations and guidelines.
Assess change control requests issued by quality or regulatory departments, evaluate regulatory impact, and develop submission strategies.
Conduct research of existing product data relative to global or regional regulatory requirements for gap analyses and regulatory submissions.
Prepare administrative and technical components of regulatory agency submissions, including IND, pre-approval packages, product registration applications, and post-approval maintenance.
Develop briefing packages for regulatory agency meetings and provide support for agency interactions.
Manage and operationalize day-to-day regulatory activities for assigned projects within agreed timelines, scope, and budget.
Serve as regulatory support on multidisciplinary project teams, contributing throughout the product lifecycle.
Act as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems.
Prepare estimates for conducting regulatory services and support client meetings to discuss proposals and project status.
Ensure compliance with global regulatory requirements and company policies and processes.
Prepare training materials and share best practices in regulatory areas internally and externally.
Participate as regulatory support in internal or external project audits.
Contribute to the creation and maintenance of SOPs and other process documentation.
Provide oversight to team members in executing their project responsibilities and escalate issues as needed.
Maintain individual training records and complete all designated required training.

Qualifications:

Minimum of 3 years of experience in CMC post-approval variation renewals, annual reports, legal entity name changes, and lifecycle maintenance activities.
MS, M.Pharm, or PhD in a science-related field or equivalent experience.
Experience in preparing regulatory submissions, including post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, with expertise in electronic submissions.
Excellent written and verbal communication skills.
Strong customer service skills with the ability to work both independently and as part of a team.
Good quality management skills.
Advanced proficiency in Microsoft Office applications.
Preferred experience with Veeva RIMS, TrackWise, and other RIMS systems.
Ability to work concurrently on multiple projects with varied requirements.
Strong analytical skills and attention to detail.
Fluency in English (written, spoken, and reading).

About Syneos Health:
Over the past 5 years, we have collaborated on 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.

Additional Information:
Tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company may assign other tasks or modify the job description without prior notice. Qualifications and equivalent experience will be assessed at the Company’s discretion.

Compliance:
Syneos Health is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations to assist employees or applicants in performing essential job functions.

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