AM/Manager(Europe Market)

The sender of this email is registered with Naukri.com as Elance Group

Experience required for the Job: 5 - 15 years Annual Salary of the Job: 6.0 - 8.0 Lacs Job Location: Gurgaon Apply Now(Send your Naukri profile to express interest to the recruiter) Dear Candidate, We would like to introduce Elance Group as leading HR consultancy. We have an opportunity for Research Scientist with a leading Pharma company. Kindly mail us your updated resume at elancegroup@consultant.com or call at 0522-4153666/09235614230 between 10am - 6pm. Key Responsibility : * Must have thorough understanding of EU and Emerging Market (Brazil, Mexico, Russia, South Africa, GCC, Turkey) regulations governing pharmaceutical products. Understanding of the PMDA, Japan requirements will be an added advantage. * Careful delegation of tasks whilst maintaining responsibility for final result * Careful planning to achieve accurate and timely results * Ability to discuss strategic and sensitive issues * Recognise recurring issues and analyse their causes in order to reach a solution * Manage all aspects of the regulatory process for EU and Emerging Market submissions, viz, review and submission of the marketing authorization application, timely and satisfactory response during the entire procedure * To prepare and co-ordinate the submission of variations, renewals, PSURs etc. * Manage a team that consists of 2-3 regulatory affairs personnel * Participate in product teams with regard to implementation of regulatory requirements * Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning * Provide regulatory expertise to analytical and formulation development teams and ensure that information is interpreted correctly * Review of the technology transfer documents with regards to EU and Emerging Market requirements * Handling of change controls * Maintain a working knowledge of regulatory requirements and guidelines and communicating changes in regulatory information to the team members * Flexibility to work for different regions, based on internal requirements, if required. Is this job relevant to you? Yes No

Your feedback would help us in sending you the most relevant job opportunities

Disclaimer: The sender of this email is registered with naukri.com as Elance Group (careers@elancegroup.com, 11-12, Green Wood Apartment, 22 Gokhle Marg, LUCKNOW, Uttar Pradesh - 226001) using Naukri.com services. The responsibility of checking the authenticity of offers/correspondence lies with you. If you consider the content of this email inappropriate or spam, you may: Report abuse by forwarding this email to: compliance@naukri.com You can also Block this Company from searching your resume in the database. Advisory: Please do not pay any money to anyone who promises to find you a job. This could be in the form of a registration fee, or document processing fee or visa charges or any other pretext. The money could be asked for upfront or it could be asked after trust has been built after some correspondence has been exchanged. Also please note that in case you get a job offer or a letter of intent without having been through an interview process it is probably a scam and you should contact compliance@naukri.com for advise. To be on the top of Employer's Resume Search Update Your Resume Now Your Resume has only 30 seconds to impress a Recruiter. Get your resume written by Experts. Call 1800-102-5557 now! (Toll-Free)