Regulatory Affairs Manager,india

Job Description	Primary Objectives: Timely and efficient product authorisation to market existing and new enzyme products used in biorefinery and food applications Build and maintain knowledge of related national product registration processes and requirements to support business strategy Primary purpose: Product registration secure and maintain product marketing authorisations of existing and new enzyme products according to business needs and maintain updated knowledge of national registration processes and requirements Main responsibilities: Prepare high quality dossiers in accordance with country specific requirements to achieve regulatory approvals / clearance for defined portfolio Act as a focal point for regulatory information relevant to products for India market Represents department in projects or product development teams Partner with the different functions including R&D, Sales and Supply Chain to communicate regulatory requirements/ information to support business needs Interact with regulatory agencies and/or trade associations within defined area(s) of responsibility/expertise Monitor regulatory changes, threats and opportunities to evaluate implications towards new and existing registrations Managing and implementing changes in global regulatory strategy, such as changes in products and processes Manage and resolve regulatory issues raised by authorities and customers (internal and externals) to secure registration approval and maintain existing portfolio Ensure compliance with applicable regulations including audits Maintain documentation and regulatory databases.
Desired Profile	Qualifications: CANDIDATE PROFILE: Relevant Experience: BS/MS in life sciences or related field, and 3-7 years experience in biotechnology, regulatory affairs or related areas. Good knowledge of scientific principles and practices related to registration of enzyme products, which may include molecular biology, toxicology and applicable general scientific methods in R&D and Quality Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents Accomplishments: Successfully represented the company in interactions with regulatory agencies, customers and/or trade associations in animal nutrition Successfully prepared dossiers and gained regulatory clearance for product(s) Successfully implemented regulatory policy(ies) Successfully impacted project team by providing regulatory guidance Noticeable influence on the success of future products and processes Technical Competencies and Skills: Consistent proactive & interpreting attitude towards clients issues and track record of strong team player. Excellent planning, organizational and communication skills. Ability to function in multidisciplinary environment. Ability to stay focused working in independent working environment Ability to prioritize, focus, and manage multiple tasks for different country registration projects Ability to interpret guidelines and regulations applicable to DuPont Industrial BioSciences products in a clear and effective manner. Ability to communicate in English (verbally and in writing) and at least one regional language, as appropriate. Competency in computer/software tools needed for job including information/data management.
Experience	3 - 7 Years
Industry Type	Chemicals / PetroChemical / Plastic / Rubber
Role	Regulatory Affairs Manager
Functional Area	Engineering Design, R&D
Education	UG - B.Sc PG - M.Sc DOCTORATE - Doctorate Not Required
Location	Gurgaon
Keywords	Regulatory Affairs, Product registration, R&D, Sales, Biotechnology
Contact	HR E I DuPont India Private Limited