Function Description: Regulatory Site Support (RSS)
Job Purpose
The Regulatory Site Support (RSS) role ensures regulatory compliance for both clinical and commercial products at the manufacturing site. The position is responsible for the accurate and timely execution of all Chemistry, Manufacturing and Controls (CMC) regulatory activities, ensuring alignment between regulatory dossiers and site manufacturing and control processes.
The RSS acts as the regulatory expert for the site, managing regulatory activities related to change controls, deviations, and inspections. This includes maintaining and updating CMC documentation (Modules 2 and 3 of the CTD) and serving as the primary regulatory point of contact for site-related projects and initiatives.
Key Responsibilities
Regulatory Compliance
* Ensure that CMC dossiers remain compliant with implemented manufacturing and control procedures at the site
* Act as regulatory subject matter expert within cross-functional project teams
* Provide regulatory intelligence to ensure project proposals align with current global regulatory guidelines and health authority expectations
* Review and approve GMP site documentation to ensure consistency with registered information and regulatory requirements, including:
* Product-specific specification sheets
* Stability protocols and reports
* Validation and qualification protocols and reports
* Analytical and process comparability plans and reports
Change Control and Deviations
* Assess (pre-assess) the regulatory impact of proposed changes and manage their regulatory implications
* Provide regulatory input for deviation investigations to evaluate potential impact on regulatory compliance
* Act as the site's regulatory interface with Global Regulatory Affairs and external partners
CMC and Regulatory Documentation Management
* Author and/or support the preparation of CMC regulatory documents and dossiers for:
* Clinical applications
* Marketing authorization applications
* Post-approval changes (global scope)
* Support maintenance of product licenses and new registrations, including:
* Periodic product license renewals
* Annual product reports for health authorities
* Site registrations and site transfers
* Proactively identify required documentation for regulatory submissions and flag potential risks related to content, quality, or timelines
* Negotiate timely delivery of high-quality technical source documents in line with project timelines
* Author and/or support responses to health authority questions, deficiency letters, and information requests related to CMC dossiers and inspections
Transversal Activities
* Act as the primary regulatory contact for Global Regulatory Affairs and external regulatory partners
* Support and participate in regulatory inspections and audits at the site
Profile
Education & Experience
* Master's degree (or equivalent) in Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related field
* 3–5 years of experience within the biotech or pharmaceutical industry
* Proven experience in CMC Regulatory Affairs
* Experience with manufacturing and/or quality operations and interactions with health authorities
* Solid knowledge of regulatory registration, license maintenance, GMP, and health-related regulations
Technical Skills & Knowledge
* Strong familiarity with CTD dossiers (Modules 2 and 3)
* Knowledge of ICH, EMA, and FDA guidelines
* Experience with Regulatory Information Management systems (e.g. Veeva Vault) is an asset
* Proficient in MS Office tools (Word, Excel, PowerPoint)
Competencies
* Excellent English communication skills, both written and verbal
* Strong technical and scientific writing skills with a high level of attention to detail
* Analytical mindset with a hands-on and transparent problem-solving approach
* Strong interpersonal and communication skills
* Ability to work effectively in a matrix organization and within cross-functional teams
* Strong organizational, prioritization, and negotiation skills
* Able to meet challenging deadlines
* Capable of working independently as well as collaboratively within project teams