The Senior Associate – Regulatory CMC, Biocides/Pesticides/Topicals/Collars, works cross functionally with Elanco R&D groups, manufacturing and quality to develop global regulatory strategy, authors submissions, oversees submission preparation and meets the reporting requirements for the Authorization and Maintenance of registrations of new animal drugs with global regulatory agencies. The role is also responsible for supporting renewals, and annual reporting requirements for approved veterinary drug products. The person must have a strong knowledge of FDA (CVM), EPA, EMA Regulations and ICH/VICH guidelines governing the authorization and post approval compliance of Veterinary Medicinal Products and Biocides/Pesticides.
- *Your Responsibilities:**
- Proven track record of overseeing end to end life cycle management (LCM) of pharmaceutical dosage forms e.g., otic solutions/suspensions, spot-on solutions, pour-on solutions/suspensions and collars
- Design/develop CMC regulatory strategy for geo-expansion of marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
- Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco.
- Lead CMC pre-submission preparation and proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams, while applying the global strategy into submissions.
- Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures
- Author high-quality CMC documentation for submission, applying CMC global regulatory strategies and assuring regulatory compliance and provide training and mentorship to CMC team members, as necessary
- *What You Need to Succeed:**
- Degree in Science (MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
- Min. 5 years in Global Regulatory Affairs, CMC (hands on experience with the Registration process of a variety of pharmaceutical dosage forms is desirable)
- Strong knowledge of FDA (CVM), EPA, EMA and ICH/VICH guidelines and regulations governing the authorization and post approval compliance of biocides/pesticides and topical products intended for veterinary use.
- Experience in developing CMC Regulatory Strategy of topical dosage forms such as otic solutions/suspensions, spot-on solutions, pour-on solutions/suspensions, collars, bee-hive strips, etc. in the US, Europe and most of the world countries is preferred.
- Understanding of the cGMP requirements (21 CFR Parts 210 & 211)
- Strong communication skills, both written and oral
- Ability to make decisions when there is no clear right or wrong answer
- Strong organizational skills and an ability to handle multiple projects at different phases of development and life cycle at the same time
- Fluency in English and good German skills
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