Regulatory Affairs Manager at IMPACT GmbH
berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

14 Jan, 27

Salary

45000.0

Posted On

16 Oct, 26

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Healthcare & Life Sciences

Description

Company: Hays Professional Solutions GmbH

Working time model: Full-time

Work location: Berlin (DE)

Job description:

Your benefits:


- Support throughout the entire application process

- Ongoing project support from our team


Your responsibilities:


- Development and implementation of regulatory strategies for new and existing drugs

- Preparation, coordination, and submission of regulatory documents to authorities

- Management of the entire product lifecycle (variations, renewals, change notifications, lifecycle management)

- Monitoring of national and international regulatory requirements and evaluation of legislative changes

- Collaboration with internal departments such as Medical Affairs, Market Access, Clinical Operations, Quality, and Commercial

- Establishing and maintaining contacts with regulatory authorities

- Ensuring compliance with regulatory requirements and internal SOPs


Your qualifications:


- A degree in pharmacy, natural sciences, biotechnology, or a comparable field

- Experience in regulatory affairs

- Sound knowledge of national and international drug approvals

- Excellent English skills

- Strong communication and project management skills


About Hays:


With over 15 years of experience in the traditional pharmaceutical, biotechnology, chemical, and medical technology industries, we know the key contacts who advertise challenging positions with potential. The high demand for personnel opens up exciting opportunities for dedicated professionals and managers to develop their careers and advance their professional development. As a specialized recruitment consultancy with an international network, we offer you decisive advantages – completely free of charge. Register now and benefit from interesting and suitable positions and projects.

Content: © Federal Employment Agency – Reference number: 13319-893545/1_622588LS-S

Responsibilities

Company: Hays Professional Solutions GmbH

Working time model: Full-time

Work location: Berlin (DE)

Job description:

Your benefits:


- Support throughout the entire application process

- Ongoing project support from our team


Your responsibilities:


- Development and implementation of regulatory strategies for new and existing drugs

- Preparation, coordination, and submission of regulatory documents to authorities

- Management of the entire product lifecycle (variations, renewals, change notifications, lifecycle management)

- Monitoring of national and international regulatory requirements and evaluation of legislative changes

- Collaboration with internal departments such as Medical Affairs, Market Access, Clinical Operations, Quality, and Commercial

- Establishing and maintaining contacts with regulatory authorities

- Ensuring compliance with regulatory requirements and internal SOPs


Your qualifications:


- A degree in pharmacy, natural sciences, biotechnology, or a comparable field

- Experience in regulatory affairs

- Sound knowledge of national and international drug approvals

- Excellent English skills

- Strong communication and project management skills


About Hays:


With over 15 years of experience in the traditional pharmaceutical, biotechnology, chemical, and medical technology industries, we know the key contacts who advertise challenging positions with potential. The high demand for personnel opens up exciting opportunities for dedicated professionals and managers to develop their careers and advance their professional development. As a specialized recruitment consultancy with an international network, we offer you decisive advantages – completely free of charge. Register now and benefit from interesting and suitable positions and projects.

Content: © Federal Employment Agency – Reference number: 13319-893545/1_622588LS-S

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