PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Job Title : Regulatory Affairs Specialist – Gurgaon/Delhi
Job ID : 128840
Job Description :
- Formulate, lead and drive the global CMC regulatory Strategy for clients for manufactured products covering registration and approval/post approval, including submission planning, risk analysis and risk mitigation plans, and facilitating global change notification approvals.
- Liaise with RA Regions Heads, to establish the submission strategy for the region and incorporate into the global RA CMC strategy.
- Manage the CMC activities within Regulatory Affairs
- Ensure CMC dossiers meet content requirements for applicable regions where registered or planning to be registered
- Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes
- Author, prepare and compile high quality, submission-ready CMC documentation for HA submissions globally
- Drive global CMC regulatory and change control policies
- Assess and communicate inspectional findings applicable to products and support CAPA projects as applicable.
- Work closely with the Global RA Head, CMC and Compliance to develop and maintain an effective Global Regulatory Affairs organization through continuous improvement initiatives that deliver business excellence.
- Manage the functional budget, resource plans and monitor progress to ensure strategic objectives of the business are achieved
- Maintain awareness of and expertise in TGA, ICH, FDA and EU guidelines relevant to role
- Oversee the development of strong working/partnering relationships with regional regulatory agencies in terms of new submissions initiatives by working through the RA
- Heads of Regions to develop manufacturing change submission strategies and to achieve global approvals of changes (i.e. FDA, Health Canada, EMA, AIFA, MHRA, TGA).
Qualifications
- Degree in biological or biotechnology, pharmacy or related field. A Postgraduate qualification is desirable.
- At least 5 years of regulatory affairs experience in CMC post-licensing life cycle management.
- Strong understanding of scientific principles relevant to the development and registration/licensing of a pharmaceutical product;
- Demonstrated knowledge of GMP and global regulatory agency expectations;
- Ability to analyse changes proposed by new legislation or ICH initiatives and to communicate the potential impact proactively to the site and senior leadership:
- Demonstrable experience of effective delivery of objectives in a complex matrix environment;
- Demonstrated ability to deal with rapid change;
- Demonstrated sound judgement and flexible approach to managing situations;
- Ability to identify “big picture” and opportunities/major issues and link day to day tasks with long term goals;
- Planning, organising and time management skills;
- Problem solving and analytical skills;
- Effective verbal and written communication skills in English in a cross functional environment;
Organization – Regulatory Affairs
Primary Location – Asia Pacific-India-Haryana-New Delhi
