CMC-D Specialist

Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here: https://www.bayer.com/en/strategy/strategy 

Main 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 AND RESPONSIBILITIES

• 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.

WHO YOU ARE

• 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, Module 3).
• 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.
• 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 would be a plus.
• Strong understanding of global CMC technical challenges, across various dosage forms and product indications (regulatory-CMC knowledge is beneficial).
• Knowledge/understanding of LATAM/Central America Regulatory guidelines and Health authorities expectations (e.g.coefepris anvisa).
• Experience in transfer of technologies would be a plus.
• Strong understanding of cGMP, principles of Quality Assurance and equivalent.
• Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.
• Communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Good English and Spanish communication skills, both written and verbal.
• 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.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people’s unique capabilities, self-experiences, and aspirations. We intentionally seek diversity, to enable our people to bring their fullest potential out and encourage others to likewise do so. Our company wins when we leverage our capabilities to lead the cultural transformation in our business, positively impacting society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.