Senior Specialist Regulatory Affairs.
Senior Specialist Regulatory Affairs
CHF850 - CHF850 per year|
Regulatory Affairs Specialist / Zürich, Switzerland / CHF 850-1050 per day
Darwin Recruitment has a new vacancy at one of our clients located in Zürich, Switzerland where we are looking to hire a temporary RA Specialist to start as soon as possible.
Start Date: October 2023 (ASAP)
Location: Zürich 1 day per week / Home office 4 days per week
End Date: December 2024 / + extensions (project duration 18-24 months)
Day Rate: Depends on experience. Approx CHF 850-1050
We are currently in search of a highly motivated and accomplished Senior Specialist in Regulatory Affairs to bolster our International Regulatory Affairs department. In this role, you will play a pivotal role in assisting with the registration of novel medicinal products and overseeing the regulatory life cycle activities for our diverse commercial product portfolio.
Global Product Oversight: Take charge of the regulatory oversight for designated medicinal products on a global scale.
Strategic Planning: Strategically plan and manage the processes associated with new marketing authorizations, renewals, and variation applications for your assigned products.
Submission Excellence: Ensure the timely preparation of meticulously crafted submission dossiers, striving for direct submission to relevant health authorities whenever possible.
Deficiency Resolution: Vigilantly track and monitor deficiency letters, commitments made to and from Regulatory Competent Authorities, and other pertinent authorities, ensuring prompt implementation and compliance.
Compliance Review: Conduct comprehensive reviews of dossier sections, with a keen focus on adherence to regulatory prerequisites.
Regulatory Authority Interaction: Engage directly with regulatory authorities throughout the entire submission preparation and assessment process, aiming for the approval of submitted regulatory documents whenever feasible.
Data Management: Maintain and update our Regulatory Information Management System, and ensure regulatory authority databases are kept current as required.
Stakeholder Engagement: Prepare for and actively participate in meetings with internal and external stakeholders.
Environmental Assessment: Continuously assess the regulatory environment to inform strategic decision-making.
Internal Guidance: Provide internal advice and regulatory information to ensure product compliance.
Educational Background: Possess a degree in biomedical sciences (Human Medicine / Pharmacy / Veterinary Medicine / Pharmaceutical Sciences) or Chemistry.
Professional Experience: Demonstrate a minimum of five years of relevant work experience in a Regulatory Affairs capacity within the pharmaceutical industry or regulatory authorities.
Regulatory Expertise: Exhibit an in-depth understanding of regulatory requirements, processes, and pathways across global markets.
Life Cycle Management: Showcase in-depth knowledge of pharmaceutical product life cycle management, with a preference for experience in generic products.
Project Leadership: Proven experience in working within project teams or leading regulatory initiatives.
Authority Interaction: Prior experience in engaging with health authorities is advantageous.
eCTD Proficiency: Familiarity with the compilation of eCTD sequences and direct submission through health authority web portals is a plus.
Interpersonal Skills: Possess the ability to effectively interact with a diverse group of individuals from various functions, nationalities, and organizational levels, both internally and externally.
Language Skills: Exhibit an excellent command of both English and German, with native German proficiency being an advantage.
This role offers a unique opportunity to become part of a dynamic organization characterized by swift decision-making and active involvement in shaping our future endeavors. Join us and be a driving force in our journey forward.
Interested? Please reply with your CV and I will contact you to book a meeting.
Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).
Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.
We do not ask for a placement fee from Candidates/Employees.
If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09
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