CMC-D Specialist

PURPOSE

Authoring of CMCD (Module 3 and QoS) documents (TRDs) for Bayer’s Consumer Health new and existing product pipeline in both New Product Development (NPD) and Post Approval Change (LCM)

YOUR TASKS & RESPOSNABILITIES

• Under the guidance of senior team members, assist in the authoring of TRDs for NPDs.
• Proactively manage the authoring of TRDs for renewals and annual reports for existing products (LCM).
• Under the guidance of senior team members, author TRDs and responses to health authority questions for LCM projects.
• Documentation admin in Regulatory Management System (Veeva Vault and equivalent), for all TRDs for NPDs and LCMs Propose and/or support category continuous improvement initiatives.
• Provide coaching and training to junior colleagues. Manage relevant functional processes.
• Manage relevant functional processes.

WHO ARE YOU

• Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, ideally with +2 years of prior hands-on experience in a technical role within the pharmaceutical, food or related industry (Analytical Development, Formulation Development, Manufacturing).
• Master’s degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent. Prior hands-on experience in a technical role within the pharmaceutical, food or related industry is preferred (Analytical Development, Formulation Development, Manufacturing) will be a plus.
• Strong understanding of global CMC technical challenges, across various dosage forms and product indications (regulatory-CMC knowledge is beneficial)
• Understanding of relevant product development processes.
• Knowledge/understanding of ICH. Knowledge of other quality systems guidelines is a plus.
• Knowledge/understanding of USP, Ph.Eur. and other relevant Pharmacopoeias.
• Strong understanding of cGMP, principles of Quality Assurance and equivalent.
• Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects with established deadlines simultaneously.
• Communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Good English communication skills, both written and verbal. Other languages are a plus.
• Detail-oriented with the ability to maintain accurate documentation and records.
• Ability to work independently and as part of a team in a fast-paced global environment.

Guided by our mission “Health for all, Hunger for none”, we deliver breakthrough innovations in healthcare and agriculture. If you’re looking to build a meaningful career in a community of creative and diverse people dedicated to making a difference, join us!

WE OFFER YOU

• • Flexible & hybrid work model
  • Career development & learning opportunities
  • Work-life balance for your physical & mental wellbeing
  • Competitive salaries & financial wellbeing (e.g. life insurance)
  • We promote employee's well-being, Inclusion & diversity and sustainability in a collaborative and innovative environment
  • We promote social engagement through our volunteering program

Location:

Spain : Cataluña : Barcelona  

Division:

Enabling Functions 

Reference Code:

838668