(April 2024- Feb 2025) (remote) Regulatory Affair Manager (m/f/d)

Are you recently out of work or looking for an temporary job to prepare for your next step in your career?

Are you a Regulatory affair associate / coordinator looking into becoming a manager ?

Your next contract is just one click away !

Contact me or simply easy apply to get your next job starting from 1st April !

Exciting Tasks:

• Acquire comprehensive knowledge of regulatory affairs regulations, policies, and procedures.
• Ensure regulatory compliance in accordance with applicable regulations.
• Compile and maintain databases and systems for regulatory documentation.
• Create and revise regulatory documents, including Common Technical Documents (CTD).
• Provide support to external clients for international product registration submissions.
• Develop and update documentation for clinical studies.
• Support submissions for Clinical Studies and Marketing Authorizations.
• Provide guidance on regulatory processes and compliance issues.
• Oversee the planning, coordination, and management of regulatory documents.
• Review, identify, and interpret relevant regulatory guidance, laws, and regulations impacting company activities.

Your Profile:

• University degree in natural sciences or equivalent qualification.
• Initial experience in the regulatory field, preferably within the pharmaceutical industry.
• Professional working Proficiency in German and English.
• Knowledge of Common Technical Document (CTD) preparation and maintenance.
• Familiarity with Clinical Trials Information System (CTIS) management is a plus.
• Ability to work under deadlines and prioritize multiple projects simultaneously.
• In-depth understanding and experience with EU regulatory requirements, including marketing authorization submissions and maintenance activities on a European level.
• Proficient in managing complex projects and timelines in a matrix team environment.
• Team-oriented, excellent communication and problem-solving skills, reliability, and an independent work ethic.

Benefits:

• Above average salary package (up to 60.000€ for the 10 months contract)
• Rare chance working directly with the head of Drug Development of a successful company
• Incredible job security (our client just pulled 20 million investment!)
• Exellent chance to step up as a regulatory affair manager
• Profound onboarding process
• Flat heirarchies and international working environment
• Flexible working enverionment (office in Berlin with remote working options)
• Great career development chance (possibility to extend contract)

The position is open now with possibilities to complete whole process and start within a month, do not miss the chance. What do you have to lose?

Contact via:

Email: nathan.honchiu@peoplewithchemistry.com

Telephone: 030767580494