Shire Regulatory CMC Manager in Strasse (Baxalta), United States

The Regulatory CMC Manager will be in charge of directing and managing Regulatory Affairs activities for developing global CMC strategies across product life cycles with a clear focus on providing collaborative support for execution of global strategies. He will report to the Director of Regulatory Affairs.

The major field of responsibilities embraces:

  • Collaborate with regulatory colleagues in Global Regulatory Affairs (GRA) to ensure global perspective and support in the preparation of global regulatory documentation in a timely manner to meet corporate objectives

  • Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies

  • Develop global CMC regulatory strategy for one or more investigational and marketed products

  • Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

  • Strongly participate in developing global CMC regulatory strategies

  • Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines

  • Significant coordination with cross-functional teams working mainly with internal customers, including QA, Technical Operations, other GRA Personnel, Pharmaceutical Sciences, Clinical Operations and occasionally works with CRO’s and regulatory agencies

Major requirements to cover this role:

  • Bachelor´s degree in pharmacy, biochemistry, chemistry , biology or related pharmaceutical field

  • Considerable experience within the pharmaceutical industry in CMC regulatory affairs, at least 3-5 years (!)

  • In-depth know-h ow of m aj or market and ICH guidelines relevant to CMC aspects of product development and maintenance

  • Relevant CMC regulatory experience in biologics, recombinant and/or small molecule regulatory activities (plasma products!)

  • Excellent collaboration, influencing and negotiation skills with the ability to establish and maintain collaborative working relationships internally and external with third party personnel

  • Very structured working style, ensuring timely submission of appropriate regulatory documents in conjunction with regulatory operations

  • Highly organized and committed to excellence, with the capability in determination and with theattention to detail

  • Self-motivated personality, who is able to set priorities and to manage challenging assignments through collaboration, communication and teamwork

  • Experience in directing interactions with regulatory authorities

  • Ability to manage complex projects, timelines and teams in a matrix team environment

  • Excellent analytical and communication skills – both verbal and written - in English and/or German (!)

  • Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.

  • Although there will be limited scope for International travel for this role, the ability to undertake International travel will be preferred

Company Insights https://youtu.be/ly_8oO-iJeU

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 4,500,- gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.

We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.