Regulatory Affairs Manager
Infos sur l'emploi
- Date de publication :13 novembre 2024
- Taux d'activité :100%
- Type de contrat :Temporaire
- Langue :anglais (Courant)
- Lieu de travail :Basel
On behalf of our client, a leading pharmaceutical company based in Basel, Swisslinx is seeking a Regulatory Affairs Manager.
Contract Type: Contract
Start Date: ASAP
Location: Basel
Workload: 100%
Duration: 6 months with possible extension
Your mission:
* Author/review CTD module 3.2 (drug substance/product) for biological products to support global regulatory submissions for the company's Clients, including clinical trial applications, BLA/MAA, and post-approval submissions.
* Manage timely responses to Health Authority (HA) queries and draft/review briefing documents for scientific advice procedures/meetings.
* Coordinate and communicate with HAs, ensuring submission deadlines are met by planning, liaising with SMEs and PMs, and collaborating on client projects.
* Escalate risks and issues to management and project teams as needed.
* Serve as RA Point of Contact or team member for assigned projects, providing regulatory guidance in client meetings.
* Conduct regulatory assessments for change controls and deviations to ensure compliance.
* Support site-specific regulatory documentation, including facility registrations, Site Master Files, Japan FMA, and type-V DMFs.
* Contribute to process improvement initiatives, leveraging Lean methodology for regulatory processes.
Your background:
* 5+ years of experience in authoring high-quality CMC CTD sections (drug substance/product) for biological products, covering phases from first-in-human to post-approval.
* Strong knowledge of CMC requirements for biologics, with a solid understanding of global regulations (EU, US, and other markets) and procedural standards.
* Bachelor's or Master's degree in Biology, Chemistry, Biochemistry, or a related field; higher education (PhD, PharmD) preferred.
* Excellent project management skills, with the ability to prioritize multiple projects in a fast-paced, deadline-driven environment.
* Experience working in contractor environments (e.g., CMO/CDMO, CRO, Consultancy) is a clear advantage.
* Fluency in English (German is a plus), with strong communication and interpersonal skills to collaborate across global teams and time zones.
* Analytical and problem-solving abilities, with a knack for logically organizing and analyzing information.
* Good knowledge of MS tools (Word, Excel, SharePoint) and proficiency in drafting and reviewing CMC documentation.
Interested?
Apply now or reach out directly to Veronika von Mentzer or Hugo Palejowski, Recruiters: Write an email, Write an email
Contract Type: Contract
Start Date: ASAP
Location: Basel
Workload: 100%
Duration: 6 months with possible extension
Your mission:
* Author/review CTD module 3.2 (drug substance/product) for biological products to support global regulatory submissions for the company's Clients, including clinical trial applications, BLA/MAA, and post-approval submissions.
* Manage timely responses to Health Authority (HA) queries and draft/review briefing documents for scientific advice procedures/meetings.
* Coordinate and communicate with HAs, ensuring submission deadlines are met by planning, liaising with SMEs and PMs, and collaborating on client projects.
* Escalate risks and issues to management and project teams as needed.
* Serve as RA Point of Contact or team member for assigned projects, providing regulatory guidance in client meetings.
* Conduct regulatory assessments for change controls and deviations to ensure compliance.
* Support site-specific regulatory documentation, including facility registrations, Site Master Files, Japan FMA, and type-V DMFs.
* Contribute to process improvement initiatives, leveraging Lean methodology for regulatory processes.
Your background:
* 5+ years of experience in authoring high-quality CMC CTD sections (drug substance/product) for biological products, covering phases from first-in-human to post-approval.
* Strong knowledge of CMC requirements for biologics, with a solid understanding of global regulations (EU, US, and other markets) and procedural standards.
* Bachelor's or Master's degree in Biology, Chemistry, Biochemistry, or a related field; higher education (PhD, PharmD) preferred.
* Excellent project management skills, with the ability to prioritize multiple projects in a fast-paced, deadline-driven environment.
* Experience working in contractor environments (e.g., CMO/CDMO, CRO, Consultancy) is a clear advantage.
* Fluency in English (German is a plus), with strong communication and interpersonal skills to collaborate across global teams and time zones.
* Analytical and problem-solving abilities, with a knack for logically organizing and analyzing information.
* Good knowledge of MS tools (Word, Excel, SharePoint) and proficiency in drafting and reviewing CMC documentation.
Interested?
Apply now or reach out directly to Veronika von Mentzer or Hugo Palejowski, Recruiters: Write an email, Write an email
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
