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CMC-D Manager
hace 2 semanas
Santanyí, España Bayer A tiempo completoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
CMC-D Manager
hace 3 semanas
At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
CMC-D Manager
Main purpose:
The purpose of this position is to ensure regulatory compliance and enable the successful launch or adaptation of Bayer products in global or local markets. Here's a breakdown of its core objectives:
Supports the maintenance of CMC Documentation (Module 3 and QoS, or equivalent for Medical devices, Food supplements and Cosmetics) for Bayer's Consumer Health new and existing products.
Authoring of CMC Documentation (Technical Registration Documents).
Tasks &responsabilities:
Under guidance of Category/Brand Heads, develop and execute CMCD strategy for new and marketed products to ensure globally approvable dossiers. Effectively manage complex post approval change and any life-cycle activities.Create or update registration files (Module 3 , QOS or technical dossier).Manage tasks associated with change requests.Manage renewal/annual reportable activities of various product license types.Documentation admin in Veeva Vault and equivalent, for all TRDs for NPDs and LCMs Under guidance of Category Heads, provide timely responses to Quality questions from global Regulatory Health Authorities.Respond to technical and regulatory questions from internal consumers (Global and Local Regulatory Affairs, consumer questions)Collaborate with R&D and Product Supply to ensure the on-time compilation of high quality dossiers from appropriate source documentation.Work closely with Regulatory to support effective Regulatory and CMC strategies. Maintain and implement knowledge of current industry requirements and best practices for CTD Module 3 and QoS or Medical devices / Food supplements / Cosmetic equivalent.Propose and/or support Category continuous improvement initiatives.Provide coaching and training to junior colleagues.
Work relationships:
CH CMCD Managers and Category Heads
* CH R&D Center of Excellence Hubs
* CH R&D Innovation Centers
* Regulatory Category and Life-Cycle Management
* Clinical Supplies
* Packaging Development
* E2E PS (including CMOs)
* Product Maintenance groups
Requirements and Qualifications:
Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, ideally with +3 years of prior hands-on experience in a technical role within the pharmaceutical, food or related industry (Analytical Development, Formulation Development, Manufacturing).
• Significant experience in CMC/Module 3 creation and response to questions
• Experience in global markets including but not limited to North America, South America, Europe, Australia, ASEAN and the Middle East
• Experience in Cosmetic Regulation in Europe is highly advantageous.
Experience in Food supplements Regulation in Europe is highly advantageous.
• Experience within Medicinal Regulatory-CMC is highly advantageous.
Strong understanding of 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.
Familiarity with regulations, regulatory requirements and industry standards.
Ability to author technical content of CMC dossier sections from suitable source documentation.
Strong understanding of cGMP, principles of Quality Assurance and equivalent.
Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.
Good communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Proficient 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.
YOUR APPLICATIONThis 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:
858905
