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Genvio Pharma Ltd. |
Job Position: Executive, Regulatory Affairs |
Job Description/ Responsibility:
- Submission of Recipe for new product licenses.
- Developing and writing clear arguments and explanations for new product licenses and license renewals;
- Preparing submissions of license variations and renewals to maintain strict deadlines;
- Liaising with, and making presentations to, regulatory authorities;
- Monitoring and setting timelines for license and renewal approvals;
- Undertaking and managing regulatory inspections;
- Negotiating with regulatory authorities about product price for marketing the product;
- Negotiating with regulatory authorities for marketing authorization.
- Preparing submissions of NOC (No objection Certificate).
- Specifying advertisement, labeling, product promotional material (PPM) and packaging requirements which approved by DGDA.
- To prepare drug clearance for raw material & finished product which release from port.
- Review and submit export related documents (form-10, COPP, FSC, NOC) to Drug Administration Department and take necessary steps for approval.
- Coordinate with all regulatory related Govt. Organizations like Department of Patents, Designs and Trademarks for regulatory purpose to fulfill the company objectives and management of overall regulatory activities.
- Preparing and coordinating documentation for regulatory purpose
Basic Qualifications
- B. Pharm./ M. Pharm from any reputed university.
- Age 25 to 30 year(s)
- 1-2 years of experience in the pharmaceutical industry
- Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Response well to questions; Writes clearly and informatively; Presents numerical data effectively
- Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviours and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
- Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices.
- Computer skills- MS Office (Word, Excel, PowerPoint and Access)
Job Nature
Full-time
Job Location
Dhaka
Salary Range
Negotiable
Other Benefits
As per company policy |
Apply Instruction:
Or
Send your CV to jobs@genvio.com.bd
Applicant must enclose his/her Photograph with CV.
Genvio Pharma Ltd.
Villa Placidium; Suite A1; House 7; Road 2/d; Block J; Baridhara, Dhaka 1212, Bangladesh
Application Deadline: November 30, 2017 |
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