Ra Manager

BioTalent are partnered with an exciting company to assist their search for a newly created Regulatory Affairs Project Manager on a permanent basis as part of their ongoing growth plans.

**Key Responsibilities**:
Maintain the approved dossiers of the lifecycle of the products

Ensure that Regulatory procedures and records with respect to CMC / Quality are in compliance with applicable regulations and standards

Prepare administrative documentation on time and Module 1 documentation for regulatory submissions / variations as well as provides support to CMC writing for initial MA submission in various regions.

Ensure that regulatory variations are accurate and verifiable against source documents to confirm compliance and traceability

Prepare submissions for new markets

Participate in expert discussions with different stakeholders’ prior approval and support by answering questions during the approval process

Maintain the Quality System for Regulatory Activities

Collaborate closely with external service providers (e.g. publisher or CMC writing) on Regulatory Affairs aspects

Support Senior Management and Line Manager in all Regulatory Affairs aspects

Collaborate with Regulatory Affairs functions within and outside of the company

Interact with Health Authorities on Regulatory Affairs aspects of the company

Manage Change control system and coordinate information to all relevant stakeholders on time

Assure post marketing surveillance regarding pharmaceutical legislation and guidance in Switzerland

**Qualifications and skills**:
You have a cooperative, self-motivated and pro-active mindset. You combine excellent planning and execution skills with the ability to work effectively in international matrix organisations.

University degree / state examination in pharmacy or other natural sciences

Proven track record of 4+ years in the pharmaceutical industry in Life Cycle Management internationally with at least 3 years of GMP/GDP experience in a regulatory function, preferably as Regulatory Affairs Project Manager

Experience of working in different regulatory regions

Sound knowledge of EU, US and CH GMP/GDP regulations, in quality system requirements, as well as from biopharmaceuticals

Good knowledge of eCTD structure and its compilation

Fluent in English