CMC RA Leadership Position – Remote – Biologics

Proclinical Staffing; Deutschland; Remote; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a skilled leader to guide a small team in the registration of biopharmaceuticals. This exciting home-based position offers a unique opportunity to work with cutting-edge technologies in a stable environment. Your role will involve technical leadership, developing regulatory strategies, and acting as the primary contact for regulatory authorities. With a focus on work-life balance, this role promises a fulfilling career path while engaging with innovative topics in the biopharmaceutical field. If you have a passion for regulatory processes and leadership, this could be the perfect fit for you.

Qualifikationen

• Several years of experience with CMC pre-approval regulatory procedures.
• Proven leadership experience in regulatory teams.

Aufgaben

• Lead a small team in the registration of biopharmaceuticals.
• Develop and implement CMC Regulatory strategy.

Kenntnisse

CMC Regulatory Procedures

Leadership Experience

Interaction with FDA

Interaction with EMA

Regulatory Strategy Development

Jobbeschreibung

What you can look forward to:

• Technical and disciplinary leadership of a small team that you will guide in the registration of biopharmaceuticals. These products are manufactured using brand-new technologies, making the workday exciting and varied as you deal with highly innovative topics.
• Home-based position, allowing for a better balance between career and personal life
• Stable employer, who has been being on the market for 20 years

Your core responsibilities:
Technical and disciplinary leadership of the team; Development and implementation of CMC Regulatory strategy; Actingas the main point of contact for the relevant regulatory authorities; Close cooperation with other regulatory teams and departments; Represent your team’s regulatory strategy in internal meetings

Location: Germany. The exact company location will be shared during a personal conversation with the headhunter.
Type of contract: Permanent employment

Mandatory requirements for the application:

Several years of experience with CMC pre-approval regulatory procedures for large molecule products;Daily interaction with FDA and EMA;Proven leadership experience;Ability to work in EU without needing additional sponsorship

Due to the high number of applications, I can only contact candidates whose qualifications match the requirements above. If your profile doesn’t fully meet the criteria, please feel free to try again next time – I look forward to your application!