Regulatory Affairs Manager

Job purpose :

• Regulatory affairs: you will be responsible of the following:

• Planning and implementation of new registrations and major changes in cooperation with central and local teams for timely approval and market launch in accordance with internal planning.
• Review of application documentations (including eCTDs) provided by central teams.
• Adaptation of the documentation according to Swissmedic guidelines, in particular module 1
• Regulatory planning and implementation of applications for changes of any kind, e.g. extension of indications, approval of new dosage recommendations or new galenic forms, license renewals, re-registrations, changes of product information, CMC variations.
• Submission of PBRERs and RMPs and other approval commitments in accordance with the specified timelines.
• Tracking of regulatory submissions in accordance with the timelines by the headquarter.
• Writing and continuous updating of the product information and uploading of texts to www.compenium.ch or www.swissmedicinfo.ch. and in internal data bases as well as internal forwarding of the updated texts in accordance with the specified internal or Swissmedic deadlines.
• Creation and approval of packaging materials in cooperation with the Artwork Coordinators in accordance with the specified deadlines
• Forwarding of the quality documents to QA required for market release

Administrative/General:

• Active cooperation with and within interdisciplinary teams (e.g. quality, marketing, medical, market access, logistics).
• Compilation of the necessary approval documentation for FOPH applications, e.g. of the Medical Department and the Corporate Affairs Department
• If appropriate, training of sales representatives on changes to the product information.

Training:

• Continuous training within the framework of internal events and regulatory training programs of the headquarter (also online)
• Participation in internal interdisciplinary meetings
• Attending further training events for further development and/or for maintaining contacts after consultation with manager

Why you?

Basic Qualifications:

• Bachelor or Master in Life Sciences in Pharmacy, chemistry, Biology or equivalent
• Languages : German native, English fluent, French B2, notions of Italian (will be an asset)
• 3 to 5 years’ of experience within Regulator Affairs’ roles in pharmaceutical (over prescription products) or any healthcare industry.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

• LI-GSK

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