\\n Regulatory & Quality Assurance Manager

Baar \\xe2\\x80\\x93 Permanent

Position: Regulatory & Quality Assurance Expert

About My Client: My client is seeking a Regulatory & Quality Assurance Expert to strengthen their team, supporting their mission to ensure the highest standards of quality and compliance within the pharmaceutical industry. While I cannot disclose the client\\xe2\\x80\\x99s name due to confidentiality, you can rest assured that you\\xe2\\x80\\x99ll be working with a renowned and trusted organisation in the field.

What We\\xe2\\x80\\x99re Looking For:

As a Regulatory & Quality Assurance Expert, you will play a pivotal role in ensuring regulatory compliance and maintaining the highest quality standards.

Here\\xe2\\x80\\x99s what my client expects from you:

Team Player with Independence: You should be able to work both independently and collaboratively within my client\\xe2\\x80\\x99s team.

Deadline-Driven: My client values a strong sense of urgency and commitment to meet regulatory time-lines.

Effective Planning and Organisation: Your skills in effective planning and organisation will help you excel in this role.

Interpersonal Skills: Good communication and interpersonal skills are essential for liaising with various internal and external stakeholders.

Time Management: You will need to manage your time effectively to handle multiple responsibilities.

Quality-Focused: A strong understanding of quality standards and a dedication to precise work are essential.

Innovative and Proactive: My client values innovative thinking and a proactive approach to regulatory challenges.

Adaptability: You should be able to think outside the box and adapt to evolving regulatory requirements.

Responsibilities:

Your main responsibilities in this role will include:

Preparing, submitting, and tracking Market Authorisation (MA) dossiers, including variations, labelling updates, and safety updates, and maintaining communication with regulatory authorities.

Supporting the development, writing, and implementation of Standard Operating Procedures (SOPs) to maintain and improve my client\\xe2\\x80\\x99s local quality assurance system.

Acting as the Deputy Responsible Person (Fachtechnisch verantwortliche Person; FvP) and Deputy Local Safety Officer (DLSO) to ensure compliance with regulatory requirements.

Key Requirements / Knowledge:

To excel in this role, you should have:

A Master\\xe2\\x80\\x99s degree in a medical, pharmaceutical, or science discipline or equivalent.

At least 1-2 years of experience in the pharmaceutical industry.

A demonstrated understanding of regulatory and compliance guidelines, including Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GVP).

Native-level proficiency in German and business fluency in English.

Proficiency in MS Office applications.

Join My Client\\xe2\\x80\\x99s Team:

If you are a driven and committed individual with a passion for regulatory affairs and quality assurance, my client invites you to apply for this position. Your expertise and dedication will contribute to my client\\xe2\\x80\\x99s mission of maintaining the highest standards of quality and compliance within the pharmaceutical industry.

ONLY CANDIDATES WITH THE RIGHT TO WORK IN SWITZERLAND CAN BE CONSIDERED\\n \\n \\n \\n \\n \\n

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