Asst. Manager, Regulatory Affairs (Local)

Job Description

Title: Asst. Manager, Regulatory Affairs (Local)

Company Name: Genvio Pharma Limited

Vacancy: 1

Job Location: Dhaka

Employment Status: Full-time

Educational Requirements:
∎ B. Pharm / M. Pharm from any reputed University.

Experience Requirements:
∎ 6 to 7 year(s)

Job Responsibilities:
∎ Having the capacity to perform all type of regulatory works with DGDA & all other regulatory authorities.
∎ Experience to handle all type of license renewal activities.
∎ Candidate must have experience on approval procedure of Recipe, Annexure, Pricing, amendment, block list, licensing inspection and other related activities.
∎ Responsible to obtain accelerated regulatory approvals of new drug products & therapies/line extensions to provide access of our innovative medicines .
∎ Responsible for licenses maintenance and regulatory compliance for established drug products to ensure uninterrupted supplies to the patients.
∎ Responsible to ensure accelerated clinical trial approvals are obtained for local data generation to aid new drug approvals.
∎ Contribute in regulatory policy related matters (directly and through industry organization) to foster regulatory environment in the country that supports accelerated access of our innovations.
∎ Gather, analyse and communicate internal and external regulatory intelligence
∎ Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
∎ Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DGDA Management
∎ Represent Affiliate Regulatory in cross-functional teams

Additional Requirements:
∎ Age 34 to 35 years
∎ Only males are allowed to apply
∎ 6-7 years of experience in the pharmaceutical industry on related field with good academically sound to obtain the post.
∎ Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds 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 behaviors 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)

Salary: Negotiable

Compensation & Other Benefits:
∎ As per company policy

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 6 Oct 2022

Company Information:
∎ 7 Sep 2022
∎ Genvio Pharma Limited

Category: Medical/Pharma

: Only males are allowed to apply

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