Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

Syneos Health

Managerial role overseeing regulatory Chemistry Manufacturing Controls strategies at Syneos Health. Engaging in preparation and submission of regulatory documentation for small molecules.

Posted 7/21/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory CMC strategies and submissions, with a strong understanding of FDA, EMA, and ICH guidelines. Capable of providing regulatory support across cross-functional teams while ensuring compliance with cGMP standards.

Highest-signal resume keywords

Regulatory CMC StrategiesCMC Submissions PreparationFDA Guidelines ProficiencyCGMP KnowledgeInterpersonal Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory CMC DocumentationChange Control AssessmentDeviation ManagementGMP InvestigationsStrategic Problem Solving

Soft Skills

Interpersonal SkillsCollaborationPlanning and PrioritizationClear CommunicationStrategic Thinking

Industry Keywords

FDAEMAHealth CanadaLATAMMiddle EastICHBiologyChemistryPharmacyRegulatory 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 small molecules
Provides regulatory support and guidance to various cross-functional teams
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 the development of global regulatory CMC strategies and submissions
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
Commitment to building an inclusive culture