Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM

Syneos Health

Regulatory CMC Consultant supporting the execution of global regulatory CMC strategies for marketed and development products at Syneos Health. Guiding cross-functional teams to ensure compliance with global regulatory requirements.

Posted 7/31/2026full-timeRemote • 🇲🇽 MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory CMC strategies and submissions, with a strong focus on compliance with global regulatory guidelines such as FDA, EMA, and ICH. Capable of providing strategic guidance and support to cross-functional teams while effectively communicating complex information.

Highest-signal resume keywords

Regulatory CMC StrategiesCMC Submissions PreparationFDA Guidelines ProficiencyCGMP KnowledgeInterpersonal Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC DocumentationCMC Submission WritingRegulatory Compliance AssessmentChange Control ManagementGMP Investigations

Soft Skills

Strategic ThinkingProblem SolvingCollaborationPlanning and PrioritizationClear Communication

Industry Keywords

FDAEMAHealth CanadaICHLATAMMiddle EastBiologyChemistryPharmacyRegulatory Affairs

About the role

Key responsibilities & impact

Support the execution of global regulatory CMC strategies for marketed and development products
Contributes to the preparation and submission of regulatory CMC documentation for a small molecule
Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Contributes to the development of global regulatory CMC strategies for commercial products
Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Requirements

What you’ll need

Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in regulatory (FDA, EMA, Health Canada, LATAM, Middle East, and ICH) guidelines
Experience in the preparation, including writing, of CMC submissions
Strategic thinking and strong problem solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization, and the ability to work with all levels of management
Capable of strategic thinking with ability to resolve complex and ambiguous situations
Sound knowledge of cGMP, FDA, EMA, ICH
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

Benefits

Comp & perks

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
Committed to building an inclusive culture