Arjun Channi Email & Phone Number

Paris, France, Fr

Responsible for the overall strategic planning and implementation of regulatory strategies in various Early and Late Stage Rare Disorders.Lead a highly agile global regulatory team to negotiate development programs with various Health Authorities globally. Lead Agency meetings and creation of meeting packets including US FDA, EMA, PMDA, ANVISA and China CDE.Act as the voice of Regulatory Affairs with cross functional business partners to enable business strategy

Paris, France, Fr

Responsible for the overall strategic planning and implementation of regulatory strategies in various Rare Lysosomal Storage Disorders.Lead a highly agile global regulatory team to negotiate late stage development programs with various Health Authorities globally. Lead Agency meetings and creation of meeting packets including US FDA, EMA, PMDA, ANVISA and China CDE.Act as the voice of Regulatory Affairs with cross functional business partners to enable business strategy

Paris, France, Fr

Regulatory stewardship of Topical, Oral and Hair categories.Lead for FDA interactions with cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA submission, labeling and advertising.Lead the regulatory strategy and execution efforts for both new products/claims as a well as the life cycle management of NDA & OTC monograph drugs, dietary supplements, cosmetics, foods, pesticides and medical devices.Review and approval of advertising and promotional materials.Leadership for regulatory strategy and intelligence for due diligence and business development initiatives.Educational resource to both internal and external customers.

New Brunswick, New Jersey, Us

Slough, Berkshire, Gb

Responsible for full end to end Regulatory Management of US FDA regulated Respiratory Healthcare products. Responsibilities include:- Working with cross functional Business partners to develop robust regulatory strategies for launch of US FDA regulated respiratory healthcare products- Claims reviews and ideation for monograph products in the respiratory space regulated by US FDA- Artwork development and review for Monograph and NDA products regulated by US FDA- End to end project management responsibilities for all aspects of the regulatory life cycle of products

Slough, Berkshire, Gb

- Supporting the Global Surface Care and Germ protection portfolio by identifying Regulatory strategies for a diverse range of product developments across a wide spectrum of geographies- Advising category development personnel on regulatory, safety and labelling related issues- Providing technical support to respond to consumer and legal inquiries concerning technical, safety, environmental and regulatory issues relating to the products- Assisting in monitoring, collecting, interpreting and sharing regulatory issues and trends impacting the products- Liaise with external trade bodies, industry associations and Governmental affairs institutions to drive Regulatory policy- Category subject matter expert on matters relating to sector specific chemical legislation such as REACH, GHS, CPR etc.

Slough, Berkshire, Gb

· Responsible for European biocidal product authorisations. · Developing an in house project management toolkit for product dossier development and submission. · Interface between R&D, Marketing and Product Safety to decide regulatory strategies for new and existing product developments. Responsible for the European product roll outs of Surface care germ protection category. · Strategising to ensure smooth approval of products. This involves liaising with European Member State competent authorities to facilitate dossier submission. · Development and maintenance of the global ingredients database system for the surface care category.

Slough, Berkshire, Gb

· Responsible for maintaining regulatory compliance for Household and Personal Care products for the UK market.· Support and feedback to R&D, Category and Local marketing Teams on Existing Product Developments from a regulatory standpoint including advertising issues.· Management of the local Artwork Approval System for all Household and Personal Care products.· Cross format and cross functional management of product compliance. Point of contact for over 15 brands and 300 SKU's.· Monitoring in-house performance and reporting on vital operational and business metrics with an aim to continuously drive and maintain efficient processes.

Gurgaon, Haryana, In

Assisted with Quality Assurance and Control operations. Worked on a number of different techniques such as HPLC, GC, LC-MS and IR. Learnt data evaluation methods and interpretation of machine outputs.

Post Graduate; Msc, Pharmaceutical Technology

B. Pharmacy, Pharmaceutical Sciences