Opening for Regulatory Affairs (Associate/Manager) @ PPD Pharma

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.

Post: Regulatory Affairs (Associate/Manager)

Job Description:
* Reviews and provides technical advice to prepare regulatory submissions Acts as subject matter expert in providing regulatory strategy advice to internal and external clients

* Provides project-specific GRA strategy, technical expertise and coordination oversight for key client projects

* Ensures quality performance for key/managed projects

* Manages project budgeting/forecasting functions

* Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with C&PD to follow through on all aspects of contract modifications

* Assists business development in pricing and securing new business by making presentations to clients, develops proposal texts and budgets in collaboration with Proposal & Contracts Dev elopment

* Matrix manages other GRA individuals assigned to support projects of responsibility

* Deputizes for functional manager in GRA as necessary

* Provides guidance, training, coaching and mentorship to other GRA personnel through liaison with the training manager

* Provides PPD staff with up-to-date legislation and guidance as it becomes available

* Ensures compliance with relevant organizational and GRA SOPs and WPDs

* Participates in launch meetings, review meetings and project team meetings

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Qualifications
* At least 6-8 years of professional experience within Regulatory

* Bachelor or higher graduate degree in science-related field

* Very good English language skills

* Attention to detail and quality of documentation

* Effective oral and written communication skills

* Ability to work on own with minimal supervision

* Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures with proven experience in at least one of the following areas;
- Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions, including for European Union and other countries.
- Development of product information for post-approval regulatory submissions
- Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies
- Regulatory submission experience in marketing authorisation applications especially for Emerging Markets (Asia-Pacific, Latin America, Middle East, Africa, E Europe)

* Basic knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc.

* Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)

* Suitable experience working in the pharmaceutical/CRO industry is preferred

Additional Information:
Experience: 6-8 Years
Location: Haryana- Nes Delhi
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 114166
End Date: 30^th Nov, 2013