Title: Global Regulatory Affairs (GRA) Vaccines/Biologics

Location: Remote - India, South America and APAC, Western EU and Canada

Position Type: 3-6 months (140 hrs. per month)

Apsida Life Science is currently partnering with a specialised clinical trial support organisation that provides decentralised clinical trial services, home healthcare, and nursing support directly to patients participating in medical research studies.

Responsibilities:

Execute global evaluations of Change Control Requests (CCRs), leveraging the STARR database, regional regulations, affiliate/excellence platform networks, and the verification of registered commitments.
Manage RSID entries within Veeva (collaborating with fellow PFPs as required) in strict alignment with internal change control Standard Operating Procedures (SOPs).
Oversee Vault Event Impact Assessments, including the creation of change types and action types with or without Hub support.

Submission Planning & Strategy:

Lead up-front planning sessions to determine submission content, timelines, and strategy in close coordination with cross-functional project teams and relevant stakeholders.
Liaise proactively with local affiliates to confirm planning parameters, actively encouraging the grouping of multiple variation packages while avoiding sequential filings wherever feasible.
Maintain comprehensive tracking records to ensure all product lifecycle activities remain on schedule, aligning closely with Regulatory Science Officers (RSOs) regarding prioritisation.

Submission Writing, Review, and Approval Coordination:

Coordinate variation authoring, review processes, and cross-site collaborations once content requirements are established, ensuring appropriate oversight from Sanofi PFPs, RSOs, and Subject Matter Experts (SMEs).
Generate appropriate Submission Content Packages (SCPs) and manage execution activities.
Finalise documents, secure necessary approvals, and manage dossier dispatch to affiliates utilising established International Variation Team workflows (Note: Annual reports and renewals follow standard GRA CMC processes).

Education:

Minimum of a University Degree in Pharmacy (PharmD), Life Sciences, Chemistry, Biotechnology, or a related scientific discipline (an advanced postgraduate degree or doctorate in regulatory affairs or clinical pharmacology is strongly preferred).
Deep familiarity with global dossier requirements, change control management, and digital regulatory systems (such as Veeva Vault and STARR databases).

If you are interested in learning more or discussing this specialized opportunity, please reach out to Sweetness Zono at Apsida Life Science:

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+44 (0) 744 134 2281

www.apsida.co.uk

Global Regulatory Affairs Consultant