Find the job you like!
search
reorder
sell

Head of Regulatory Affairs Development (m/w/d) (DE)

[5412]
Head of Regulatory Affairs

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment.  We are searching for a Head of Global Regulatory Affairs Development (m/w/d) Your tasks ·Manage and develop the regulatory affairs development team, consisting of global regulatory leads (GRLs) located in Europe and US.  ·Provide guidance and coaching to individual team members to optimize growing opportunities.  ·Act as an in-house regulatory expert, advising and supporting the global regulatory leads.  ·Oversee the implementation of global regulatory strategies taking into consideration the overall development program objectives and corporate goals.  ·Contribute to the global regulatory strategy (developed by the GRL) and execution plan to accelerate access to market, when appropriate.  ·Keep management informed about significant regulatory risks, non-compliance and risk mitigation and communication plans.  ·Serve as a strategic and functional partner with internal stakeholders; Collaborate with leaders within other R&D functions to promote drug development efficiency, innovation while optimizing probability of success.  ·Work collaboratively with the head of US RA and global labeling, head of Regulatory CMC and head of regulatory operation, to build an efficient working environment, ensuring input from different reginal or regulatory functions are considered in the development of the regulatory strategy  ·Participate in the review and sign off of key submission documents (clinical trial applications, marketing authorization applications, pediatric plan, briefing document, orphan drug designation etc..).  ·Ensure all submissions made to health authorities meet high quality, regulatory and scientific standards. ·Ensures process and resources are in place to allow timely review and delivery of regulatory strategies / submission dossiers.  ·Participate in in-licensing and/or out-licensing due diligences, when appropriate.  ·Conduct and share regulatory intelligence with the regulatory affairs team.  ·Develop & support regulatory trainings. Partner with global regulatory authorities to influence and develop emerging regulatory guidelines, as well as interpreting and sharing emerging regulatory guidance from various regulatory authorities, when appropriate. Your qualifications ·Life science degree·(Pharmacy, Medicine, Science).  ·Around 15 years’ experience within the biotech or pharmaceutical industry.  ·Solid experience in supporting the full spectrum of drug development from phase 1 to registration and life cycle management.  ·Extensive experience in regulatory affairs and interaction with Health authorities globally; proven track record of working on and successfully completing complex, global regulatory projects, including marketing authorization applications (MAA, NDA, BLA).  ·Demonstrated competencies of strategic work, critical thinking, and innovation, with the ability to be hands on when needed.  ·Strong leadership skills with experience in shaping and implementing regulatory affairs processes and global working models; possess excellent interpersonal skills, with the ability to influence and collaborate effectively with colleagues across different expertise and across different regions (mainly US and Europe).  ·Experience with Oncology and rare disease is a plus.  ·Excellent organizational skills required with the ability to handle multiple priorities and meet deadlines.  ·Excellent communication and presentation skills.  Für weitere Fragen steht Ihnen gerne Herr Tilman Grumbd unter der Rufnummer +49 441 21879-34 oder via E-Mail an tilman.grumbd@optares.de zur Verfügung.

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment. 

We are searching for a


Head of Global Regulatory Affairs Development (m/w/d)

Your tasks
  • Manage and develop the regulatory affairs development team, consisting of global regulatory leads (GRLs) located in Europe and US. 
  • Provide guidance and coaching to individual team members to optimize growing opportunities. 
  • Act as an in-house regulatory expert, advising and supporting the global regulatory leads. 
  • Oversee the implementation of global regulatory strategies taking into consideration the overall development program objectives and corporate goals. 
  • Contribute to the global regulatory strategy (developed by the GRL) and execution plan to accelerate access to market, when appropriate. 
  • Keep management informed about significant regulatory risks, non-compliance and risk mitigation and communication plans. 
  • Serve as a strategic and functional partner with internal stakeholders; Collaborate with leaders within other R&D functions to promote drug development efficiency, innovation while optimizing probability of success. 
  • Work collaboratively with the head of US RA and global labeling, head of Regulatory CMC and head of regulatory operation, to build an efficient working environment, ensuring input from different reginal or regulatory functions are considered in the development of the regulatory strategy 
  • Participate in the review and sign off of key submission documents (clinical trial applications, marketing authorization applications, pediatric plan, briefing document, orphan drug designation etc..). 
  • Ensure all submissions made to health authorities meet high quality, regulatory and scientific standards.
  • Ensures process and resources are in place to allow timely review and delivery of regulatory strategies / submission dossiers. 
  • Participate in in-licensing and/or out-licensing due diligences, when appropriate. 
  • Conduct and share regulatory intelligence with the regulatory affairs team. 
  • Develop & support regulatory trainings. Partner with global regulatory authorities to influence and develop emerging regulatory guidelines, as well as interpreting and sharing emerging regulatory guidance from various regulatory authorities, when appropriate.

Your qualifications

  • Life science degree·(Pharmacy, Medicine, Science). 
  • Around 15 years’ experience within the biotech or pharmaceutical industry. 
  • Solid experience in supporting the full spectrum of drug development from phase 1 to registration and life cycle management. 
  • Extensive experience in regulatory affairs and interaction with Health authorities globally; proven track record of working on and successfully completing complex, global regulatory projects, including marketing authorization applications (MAA, NDA, BLA). 
  • Demonstrated competencies of strategic work, critical thinking, and innovation, with the ability to be hands on when needed. 
  • Strong leadership skills with experience in shaping and implementing regulatory affairs processes and global working models; possess excellent interpersonal skills, with the ability to influence and collaborate effectively with colleagues across different expertise and across different regions (mainly US and Europe). 
  • Experience with Oncology and rare disease is a plus. 
  • Excellent organizational skills required with the ability to handle multiple priorities and meet deadlines. 
  • Excellent communication and presentation skills. 

Für weitere Fragen steht Ihnen gerne Herr Tilman Grumbd unter der Rufnummer +49 441 21879-34 oder via E-Mail an tilman.grumbd@optares.de zur Verfügung.


map Planegg, Deutschland date_range 28.02.2022 update Permanent
Qualitätswesen


No suitable job? Send us a message!

No suitable job for you? No problem! Just send us your name, your e-mail address and a short description of your desired job. We will get back to you immediately with matching positions!