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Regulatory Affairs Consultant - CTA
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Consultant, Client
Projektbeschreibung
Our client, global pharmaceutical company has an opportunityan experience Regulatory Affairs Consultant to join a busy team to support global clinical trial application submissions.
This is a contract position for 12 months and based in Basel, Switzerland.
YOUR DAILY TASKS: Responsible for implementing regulatory strategy and managing operational activities for EU/EEA and AMAC regions.
Provides input into global regulatory strategy including identification of gaps or risks in global strategic plan for assigned regions.
Partners with regions to align on regulatory strategy in order to fulfil business objectives
Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and internal stakeholders
Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.
Facilitates preparation and finalization of briefing books for HA meetings and contributes to preparation of summary documents.
Develops and implements plans for timely response to HA requests and coordinates responses.
Leads rehearsals for HA meetings as appropriate.
Serves as local HA liaison for EMA.
Implements strategy for EU/EEA and AMAC regions in line with global strategy.
Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval. Proposes options to minimize risk.
Drives coordination, planning, and submission of dossiers in EU/EEA and AMAC regions.
Review of global dossier summary documents.
Develops and implements plans to avoid/minimize clock stops during submission review.
Compiles, reviews and submits Clinical Trial Applications (CTAs).
IDEAL BACKGROUND:
Life science degree
Strong knowledge of regulatory submission and approval processes in EU/EEA region, leading regulatory submissions and approvals,
working in a global/Matrix environment or cross-functional teams in the pharmaceutical industry,
HA negotiations,
Prior Regulatory Affairs experience
Drug development process knowledge
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
This is a contract position for 12 months and based in Basel, Switzerland.
YOUR DAILY TASKS: Responsible for implementing regulatory strategy and managing operational activities for EU/EEA and AMAC regions.
Provides input into global regulatory strategy including identification of gaps or risks in global strategic plan for assigned regions.
Partners with regions to align on regulatory strategy in order to fulfil business objectives
Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and internal stakeholders
Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.
Facilitates preparation and finalization of briefing books for HA meetings and contributes to preparation of summary documents.
Develops and implements plans for timely response to HA requests and coordinates responses.
Leads rehearsals for HA meetings as appropriate.
Serves as local HA liaison for EMA.
Implements strategy for EU/EEA and AMAC regions in line with global strategy.
Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval. Proposes options to minimize risk.
Drives coordination, planning, and submission of dossiers in EU/EEA and AMAC regions.
Review of global dossier summary documents.
Develops and implements plans to avoid/minimize clock stops during submission review.
Compiles, reviews and submits Clinical Trial Applications (CTAs).
IDEAL BACKGROUND:
Life science degree
Strong knowledge of regulatory submission and approval processes in EU/EEA region, leading regulatory submissions and approvals,
working in a global/Matrix environment or cross-functional teams in the pharmaceutical industry,
HA negotiations,
Prior Regulatory Affairs experience
Drug development process knowledge
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Organisation/Management