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Our client is an international solid, responsible and growing pharmaceutical company based in Ticino.
For this exclusive research, we are looking for a successful candidate to fill the position of:
CMC Regulatory Specialist
full time permanent employment in a young working environment and positive culture.
Essential tasks and responsibilities:
· Working in the Pharmaceutical Development Department, collaborates with Regulatory Affairs and Technical Departments to develop regulatory CMC strategies, identify potential regulatory risks and develop appropriate contingency plans for projects in various phases of development and product related activities;
· Assists in managing timelines and submission planning for regulatory CMC dossier;
· Identifies the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines.
· Plans and prepares CMC documentation during product registration and variation applications, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance.
· Coordinates the timely and accurate assembly of responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
· Prepares meeting materials and attend/lead government health authority meetings in conjunction with CMC drug development activities and submissions;
· Reviews post-approval CMC changes (change controls) and assess the regulatory impact on affected registrations in collaboration with Regulatory Affairs. Contribute to regulatory strategies and coordinate filings of variations, as appropriate.
· Exercises good judgment in elevating and communicating actual or potential issues in relation to manufacturing, quality or analytical for regulatory submissions;
· Keeps knowledge up to date regarding regulatory and quality guidelines.
· Works collaboratively with global colleagues and partners and provide support, as required
· Uses effective communication and employs influencing skills to establish key relationships with internal/external contacts.
· Assists in development of best practices for Regulatory Affairs processes.
Required skills and core competences:
· Bachelor/Master degree in related technical science (Chemistry, Pharmacy or equivalent)
· 5 or + years' experience in the Pharmaceutical field
· Fluency in French and English will be considered an asset
· Strong relational, communication and adaptability skills
· Ability to work independently and as part of a team
Interested candidates should send their CV by email to Cristina Robotti at firstname.lastname@example.org or by post to the address below.
For further information please call the following number: +41 91 911 30 00.
We thank all applicants for their interest, but only candidates selected for an interview will be contacted.
MAXIMUM DISCRETION AND PROFESSIONALISM FULLY GUARANTEED.