Regulatory Affairs Manager (Pre- Approval) - DEMO Global Services
The Regulatory Affairs Manager (Pre- Approval) will lead regulatory strategy and submission readiness for assigned development products from early development through first approval. The role integrates product, formulation, process, analytical, stability, nonclinical, clinical and device information, as applicable, to identify regulatory risks, influence development decisions and establish scientifically defensible regulatory positions. The Manager will combine strategic scientific judgement with disciplined dossier planning, review and submission execution.
Responsibilities
- Develop and maintain product-specific regulatory development plans covering legal basis or pathway, target markets, reference product strategy and authority engagement.
- Provide early regulatory input into formulation selection, process parameters, control strategy, analytical method development, stability plans, study designs and device development activities, as applicable.
- Translate product and development science into clear regulatory positions, including the rationale, assumptions, gaps, risks and proposed mitigations.
- Identify emerging, non-obvious or insufficiently addressed regulatory and technical risks early and recommend alternative strategies to mitigate risks.
- 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 and defensibility.
- Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones.
Experience and Qualifications
- Minimum 8 years of relevant pharmaceutical or biopharmaceutical industry experience.
- Minimum 6 years of hands-on Regulatory Affairs experience.
- Minimum 3 years of direct experience in development or pre-approval regulatory strategy, major submissions, scientific advice or substantive health-authority interactions.
- Demonstrated ownership of regulatory strategy for development products or programs, including management of material technical or regulatory risks.
- Hands-on experience in at least one major regulated market, such as the European Union, United States, United Kingdom, Canada, Australia, Japan or WHO Prequalification, as relevant to the portfolio.
Required Skills
- Strong knowledge of applicable relevant global regulatory frameworks.
- Strong working knowledge of CTD/eCTD structure and the relationship between source development data, summaries and final dossier content.
- Working knowledge of applicable ICH quality guidelines and relevant multidisciplinary, nonclinical and clinical guidance based on assigned product modality.
- Ability to critically assess formulation, process, analytical, impurity, characterization, stability, comparability and control-strategy conclusions from a regulatory-risk perspective.
- Clear scientific writing, structured problem-solving, executive communication, influencing and constructive challenge.
- Ability to manage multiple products, competing priorities and time-sensitive decisions with appropriate escalation.
Added Advantage
- Experience with complex injectables, biologics/biosimilars, drug-device combination products or other technically complex dosage forms.
- Experience in formal health-authority meetings, scientific advice or major deficiency-response strategy.
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
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