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