Consultant, Regulatory Operations

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G we enable our people to build careers that impact positively on their quality of life. Through our expertise insight consulting and management skills we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful varied and thought-provoking work with a strategic emphasis a solutions-driven approach and significant real-world outcomes from science to delivery/success. To learn more about who we are and what drives us watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow we support them in their learning and we reward them in so many different return they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpaces prestigious Best Places to Work 2026 award for the third consecutive year along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees with a particular emphasis on culture career growth and development opportunities financial rewards leadership and innovation.

At Syner-G we recognize that our team members are our most valuable asset. Join us in shaping the future where your talents are valued and your contributions make a meaningful impact.

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POSITION OVERVIEW:

The Consultant Regulatory Operations will support the preparation formatting compilation publishing validation and dispatch of regulatorysubmissions in accordance with applicable regional requirements internal proceduresand project timelines. This role is responsible for assisting with submission-readydocument preparation eCTD publishing activities technical validation checks andlifecycle submission support for dossiers such as IND NDA ANDA MAA variationsrenewals amendments and responses as applicable.

The position requires hands-on support in regulatory document conversionhyperlinking bookmarking PDF quality checks eCTD sequence preparation validationusing approved tools and submission dispatch through relevant health authoritygateways under the guidance of senior team members. The role also involvescoordination with CMC Regulatory Affairs Labelling Clinical Quality and other cross-functional teams to ensure timely collection organization and processing of documentswhile maintaining accuracy compliance and audit-ready documentation standards.

WORK LOCATION:

Remote position based in Bangalore Chennai Hyderabad or Mumbai with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Prepare convert format and quality check regulatory documents includingclinical nonclinical CMC labelling and administrative documents to ensure theyare submission-ready and compliant with applicable formatting standards.

• Perform document-level activities such as PDF conversion hyperlinking bookmarking pagination checks document property verification file naming checks and technical readiness review as per internal procedures and submission requirements.

• Support compilation and publishing of assigned regulatory submissions in eCTD format using approved publishing tools under the guidance of senior team members.

• Assist in preparation of regulatory submissions including IND NDA ANDA MAA variations renewals amendments supplements and responses to health authority queries as applicable.

• Perform eCTD sequence preparation document placement leaf title checks metadata review and lifecycle operator checks in accordance with regional regulatory requirements and internal checklists.

• Conduct technical validation of assigned submissions using approved validation tools and support resolution of validation errors or warnings in coordination with senior team members.

• Support dispatch of submissions through applicable health authority gateways or portals such as FDA ESG EMA Gateway/Web Client MHRA Submissions Portal and other regional systems as required.

• Maintain accurate publishing records validation reports submission acknowledgements dispatch confirmations and related documentation to ensure audit-ready traceability.

• Coordinate with CMC Regulatory Affairs Labelling Clinical Quality and other cross-functional teams for timely receipt review organization and processing of documents required for regulatory submissions.

• Track assigned publishing activities timelines pending documents validation status and submission milestones and provide timely updates to senior team members and stakeholders.

• Follow applicable ICH guidelines regional eCTD specifications internal SOPs work instructions naming conventions quality checklists and document management requirements while performing assigned activities.

• Escalate document quality issues publishing challenges validation errors missing inputs timeline risks or technical system issues in a timely manner to ensure submission continuity and compliance.

• Support routine use of regulatory operations tools such as Lorenz DocuBridge Lorenz e-validator ISI Toolbox Adobe Acrobat Pro RIM systems and document management systems for assigned activities.

• Contribute to process improvement initiatives standardization of publishing practices checklist updates and digitization activities within Regulatory Operations as assigned.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelors degree in life sciences pharmacy regulatory affairs biotechnology or a related discipline.

Experience:

• Minimum 2 years of relevant experience in regulatory publishing regulatory operations eCTD compilation submission formatting validation or related pharmaceutical/biologics regulatory submission activities.
• Hands-on experience in regulatory document preparation PDF conversion hyperlinking bookmarking pagination checks file naming checks document property verification and submission-readiness review.
• Working knowledge of eCTD publishing activities including sequence preparation document placement leaf title review metadata checks lifecycle operator checks and technical validation support.
• Experience using publishing validation and document management tools such as Lorenz DocuBridge Lorenz e-validator ISI Toolbox Adobe Acrobat Pro RIM systems or equivalent tools.
• Basic understanding of ICH guidelines regional eCTD specifications health authority submission requirements internal SOPs quality checklists and document management practices.
• Ability to support submission types such as IND NDA ANDA MAA variations renewals amendments supplements and responses to health authority queries as applicable.
• Experience supporting technical validation checks and assisting in resolution of validation errors warnings document quality issues and publishing-related queries under guidance.
• Good coordination skills with the ability to work with CMC Regulatory Affairs Labelling Clinical Quality and other cross-functional teams for timely receipt and processing of submission documents.
• Strong attention to detail accuracy timeline orientation and ability to maintain audit-ready publishing records validation reports acknowledgements and dispatch confirmations.
• Good written and verbal communication skills with the ability to provide timely updates escalate issues appropriately and work effectively under supervision in a deadline-driven environment.

Skills and Attributes:

• Prior exposure to regulatory publishing activities for multiple regions such as US EU UK Canada and other international markets.

• Working familiarity with health authority gateway or portal submissions including FDA ESG EMA Gateway/Web Client MHRA Submissions Portal CESP or other regional submission portals.

• Experience supporting lifecycle management submissions including variations renewals amendments supplements annual reports and responses to health authority questions.

• Familiarity with submission tracking acknowledgement tracking validation report archival dispatch confirmation maintenance and audit-ready publishing documentation.

• Basic knowledge of regulatory information management systems document management systems and electronic submission archive practices.

• Awareness of publishing quality control practices including peer review checklists technical document checks folder structure verification and sequence readiness checks.

• Ability to support process improvement standardization automation or digitization initiatives within Regulatory Operations.