CMC-D SPECIALIST

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.
., 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.
., 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.
ur.
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.
.
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     YOUR APPLICATION       This is your opportunity to tackle the world’s biggest challenges with us.
Maintaining our health, feeding growing populations and slowing the rate of climate change.
You have a voice, ideas and perspectives and we want to hear them.
Because our success begins with you.
Be part of something big.
Be Bayer.    Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
We are committed to treating all applicants fairly and avoiding discrimination.
      Location.
Spain.
Cataluña.
Barcelona      Division.
Enabling Functions     Reference Code.