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

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details

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

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Meet
Meet

Current Openings: 0

Life Sciences Affects Us All. At Meet, we champion the people who work in Life Sciences, share the purpose of the companies who innovate in it and create the teams that drive the future of global health. With companies looking to find the best talent to move forward and life sciences professionals eager to hear about the opportunities to give them a career they want - Meet listens, engages and understands you. Making your experience with us a memorable one. At Meet, we offer dynamic recruitment and talent solutions covering both permanent and contract positions from middle management through to executive level. Our teams focus on specific Life Sciences disciplines, positioning themselves as experts in the industry. We tailor each search to you. As well as a full range of recruitment services, Meet is there to support and enhance your wider talent strategy. Our dedicated data insights team provides extensive insight into the market and global trends to inform decision making, shape company policy and ultimately attract the best life sciences talent. Combined with our Client Partners team you’re assured that you’re treated more than just a number. We’re here to support your goals, your hopes and your passions. Whether as an individual in your career journey or as a business with your recruitment and talent strategy. Our philosophy is simple; to provide exceptional, personalised service. But realising it takes dedication and hard work. This is why we’ve assembled such a remarkable team of professionals to make it a reality for you: people with passion, people with talent, people with chemistry.
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