Manager Dra Jobs Vacancy in Smart Talent Faridabad
Smart Talent Faridabad urgently required following position for Manager Dra. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Manager Dra Jobs Vacancy in Smart Talent Faridabad Jobs Details:
Designation : SR. Manager DRA
EXPERIENCE : — 10 + YEARS
Salary— NO BAR
AGE : — NOT MORE THAN 45 YEARS
JOB LOCATION: – FARIDABAD
Preferred : Male candidate with age not more than 45 years.
SKILLS NEEDED: — Regulatory Affair Having a vast experience of DRA and having a very stable
profile. He should also have experience of US FDA & MHRA.
Job Role & Responsibilities :
- Able to handle team of 5 to 6 employee of DRA department.
- Ensuring that a company’s products comply with the regulations of the MHRA.
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to collecting, collating and evaluating scientific data that has been researched by colleagues.
- Developing and writing clear arguments and explanations for new product licenses and license renewals.
- preparing submissions of license variations and renewals to strict deadlines.
- Monitoring and setting timelines for license variations and renewal approvals, working with specialist computer software and resources.
- Preparation of Dossiers – CTD (Common Technical Dossier) and ACTD (Asian Common Technical Dossier).
- Experience on dossier preparation -CTR, ACTR formats , CTS, GCC countries.
- Completer knowledge of BE & clinical trails.
- To do Gap Analysis & amp Reviewing documents received from plant QA/QC & amp keep-uping records.
- To do Gap Analysis in the Loan License / Third party data for dossier requirement. Co-ordination with plant – production & amp packing for samples and documents.
- Abreast with current guidelines of registration of different countries and share with team. Handling queries & amp deficiencies received from Authorities.
- Reviewing of documents received from CROs, FR& amp D ADL. Checking data like Stability, Specification & amp Standard Test Methods, Standard Operating Procedure, Certificate of Analysis, Checking MFR & amp BMR for correct calculations.
- writing clear, accessible product labels and patient information leaflets planning and developing product trials and interpreting trial data.
- advising scientists and manufacturers on regulatory requirements.
- providing strategic advice to senior management throughout the development of a new product
- project managing teams of colleagues involved with the development of new products undertaking and managing regulatory inspections.
- reviewing company practices and providing advice on changes to systems liaising with, and making presentations to regulatory authorities;
- negotiating with regulatory authorities for marketing authorization.