Regulatory Affairs Senior Associate (Pre - Approval) - DEMO Global Services
The Regulatory Affairs Senior Associate will work at the interface of R&D and Regulatory, building a genuine technical understanding of the product's formulation and analytical profile to support sound regulatory strategy. This is not a document-processing role — it requires the ability to engage with development science, identify potential issues, and contribute informed regulatory thinking rather than just administrative submission support.
Responsibilities
- Develop a working technical understanding of assigned products — formulation composition and rationale, manufacturing process, and analytical/impurity profile — sufficient to identify regulatory implications independently.
- Review R&D and Analytical data, including formulation trials, stability studies, method validation and characterization data, critically to spot gaps, inconsistencies or risks.
- Support the Manager/Director in framing regulatory strategy by contributing well-reasoned technical inputs.
- Assess the regulatory impact of significant development changes and ensure that comparability, bridging or additional evidence requirements are addressed prospectively.
- Prepare and/or review assigned dossier sections, briefing packages and responses to major authority questions, ensuring completeness.
- Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones.
Experience and Qualifications
- Minimum 4 years of relevant pharmaceutical or biopharmaceutical industry experience.
- Minimum 2–3 years of genuine exposure in R&D, either formulation development and/or analytical sciences.
Required Skills
- Understanding of and hands-on experience with regulatory dossier structure and requirements, including CTD/eCTD, is preferred, though the primary emphasis of this role is technical/scientific understanding over document compilation.
- Strong analytical thinking and the confidence to raise technical concerns proactively.
- Clear written and verbal communication skills for cross-functional technical discussions.
- Ability to manage multiple deliverables independently within defined timelines.
Added Advantage
- Experience with complex injectables, biologics/biosimilars, drug-device combination products or other technically complex dosage forms.
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
Similar roles
Portfolio Manager – Life Insurance
Southern Cross Medical Care Society·New Zealand
About us Southern Cross Health Insurance is shaping a healthier Aotearoa New Zealand. Our purpose is simple: empowering our members to live well for longer. We're here to give peace of mind through timely access to quality care, inspire healthier living, and lead positive change across the health system. As a New Zealand-owned, member-based organisation, we're building a future where…
- Full-time
- Skilled Migrant (Residence) — PR, points-based, no single employer
Jungkoch/Jungköchin M/W/D
Haus Hirt Hotel & Spa·Bad Gastein, Austria
Hotel Haus Hirt in Badgastein - klein und fein, geheimnisvoll und faszinierend - unkomplizierte Gastlichkeit mit Herz, Tradition und mehr. Das gewisse Extra, das sich zwar nicht beschreiben lässt, aber das den Abschied sehr, sehr schwer macht. Haus Hirt wurde ausgezeichnet: * Gault Millau Hotel des Jahres 2019 (in der Kategorie "die besten Geheimtipps") * 1 Relax-Lilie - 14 Punkte…
- Full-time
Security Engineering Lead
Wehrtyou·United States
<p>Hudson River Trading (HRT) is seeking an experienced Security Engineer to join our growing Enterprise Security team. This team is responsible for securing the systems and tools HRT employees rely on every day, including managing AI security, Cloud Security Posture Management (CSPM), Identity and Access Management (IAM), Public Key Infrastructure (PKI), Endpoint Security, Vulnerability Management, and protecting HRT’s infrastructure across…
- On-site
- Full-time
Go-to-Market - Cambridge, United Kingdom
speechify·Cambridge, United Kingdom
<p><strong>Mission</strong></p> <p>The mission of Speechify is to make sure that reading is never a barrier to learning. Over 50 million people use Speechify's text-to-speech products to turn whatever they're reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Google recently named Speechify the Chrome Extension of the…
- On-site
- Full-time
Go-to-Market - Belfast, United Kingdom
speechify·Belfast, United Kingdom
<p><strong>Mission</strong></p> <p>The mission of Speechify is to make sure that reading is never a barrier to learning. Over 50 million people use Speechify's text-to-speech products to turn whatever they're reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Google recently named Speechify the Chrome Extension of the…
- On-site
- Full-time
Steuerberater (m/w/d) in Korb, auf Wunsch mit Partnerperspektive, gesucht - mindestens 90.000€
Taxtalente.de·Korb, Germany
TaxTalente ist die Nr. 1 Job-Matching Plattform für Jobsuchende in der Steuerberatung. Sie suchen eine positive berufliche Veränderung? Sie möchten den nächsten Schritt in Ihrer Karriere gehen und streben möglicherweise sogar eine Partnerschaft in einer zukunftsorientierten Kanzlei an? Sie möchten endlich wieder in einem positiven Arbeitsumfeld arbeiten, in dem Sie finanziell und persönlich wertgeschätzt werden? Sie suchen nach Tätigkeiten, die…
- On-site
- Full-time
- Blue Card — tied; settle 21–33mo
Steuerberater (m/w/d) in Plaidt, auf Wunsch mit Partnerperspektive, gesucht - mindestens 90.000€
Taxtalente.de·Plaidt, Germany
TaxTalente ist die Nr. 1 Job-Matching Plattform für Jobsuchende in der Steuerberatung. Sie suchen eine positive berufliche Veränderung? Sie möchten den nächsten Schritt in Ihrer Karriere gehen und streben möglicherweise sogar eine Partnerschaft in einer zukunftsorientierten Kanzlei an? Sie möchten endlich wieder in einem positiven Arbeitsumfeld arbeiten, in dem Sie finanziell und persönlich wertgeschätzt werden? Sie suchen nach Tätigkeiten, die…
- On-site
- Full-time
- Blue Card — tied; settle 21–33mo
Steuerberater (m/w/d) in Thermalbad Wiesenbad, auf Wunsch mit Partnerperspektive, gesucht - mindestens 90.000€
Taxtalente.de·Thermalbad Wiesenbad, Germany
TaxTalente ist die Nr. 1 Job-Matching Plattform für Jobsuchende in der Steuerberatung. Sie suchen eine positive berufliche Veränderung? Sie möchten den nächsten Schritt in Ihrer Karriere gehen und streben möglicherweise sogar eine Partnerschaft in einer zukunftsorientierten Kanzlei an? Sie möchten endlich wieder in einem positiven Arbeitsumfeld arbeiten, in dem Sie finanziell und persönlich wertgeschätzt werden? Sie suchen nach Tätigkeiten, die…
- On-site
- Full-time
- Blue Card — tied; settle 21–33mo
