Technical Regulatory Support Manager (f/m/d)

Technical Regulatory Support Manager (f/m/d) – German / regulatory affairs / CMC Data / regulations / biotechnology

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical Regulatory Support Manager

Background:
Technical Regulatory has a key role in the process of developing new medicines and making them available to patients world-wide. We provide the strategy, expertise and guidance to ensure world-class technical regulatory support for the chemistry, manufacturing and controls (CMC) section of clinical trial licensure applications, new market applications, and post-approval changes. We are part of internal development and marketed product teams and collaborate with health authorities and industry groups world-wide.

The perfect candidate has a degree within life sciences or regulatory affairs and has collected first hands-on experience in technical regulatory affairs, with profound knowledge on national and international regulations. Storing project management skills as well as an affinity for IT tools are key to this role.

Tasks & Responsibilities:
Proactively support the technical regulatory department on the execution of submission-related and administrative activities for global technical registrations
* Effectively manage regulatory changes throughout the product life cycle
* Be responsible for preparation and maintenance of CMC documentation in internal document management systems as well as support associate activities
* Represent PTR on other cross-functional teams, advise cross-functional teams concerning regulatory requirements and work with diverse partners and personalities
* Ensure regulatory compliance together with local and global technical functions as well as assess technical change records for regulatory impact
* Contribute to excellence by finding opportunities, mitigating risks and supporting continuous improvement
* Contribute to driving efficiency by assertively simplifying, trying new ways and cutting out waste
* Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections
* Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
* Monitors and improves tracking/control systems
* Keeps abreast of regulatory procedures and changes
* Direct interaction with regulatory agencies on defined matters
* Recommends strategies for earliest possible approvals of clinical trials applications

Must Haves:
Must have a Bachelor’s degree – preferably in a scientific field; an advanced degree is a plus
* First hands on experiences ideally in technical regulatory affairs, with profound knowledge on national and international regulations and biotechnology
* Ability to manage projects and have excellent communication skills in English, German is a plus
* Ability to work with IT systems and have a high sense of responsibility concerning CMC data management
* Ability to work in interdisciplinary teams, global project teams and with several interfaces
* Ability to work in a diverse and changing, global environment as a positive challenge with multiple opportunities.
* Strong communication skills, ability to work in a team, proactivity and flexibility
* Ability to prioritize and work effectively both within a team environment and independently
* Ability to be open, curious and willing to experiment with New Ways of Working
* You are comfortable with taking risks, experimentation and ambiguity
* You take ownership, are decisive, and use your knowledge, network and creativity to solve problems and progress programs and projects

Reference Nr.: 922952SGR
Role: Technical Regulatory Support Manager
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.12.2023
Duration: 12 month

Deadline: 16.10.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.