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Justin Michael

Tender & Regulatory Executive Officer

 

Summary

 

A master’s degree holder in M.Pharm (General) with 7 years of experience with Pharmaceutical Drug Regulatory Affairs &
good communication skills with utmost interest in the health and well-being of the Bangladeshi Pharmaceutical Sector.

 

Skills

  • Excellent proficiency on Drug Regulatory Affairs, Microsoft Word, Excel & Power point work.

 

Work Experience

 

Tender & Regulatory Executive Officer

Gonoshasthaya Pharmaceuticals Limited

Oct 2015

 

Directorate General of Drug Administration: (Only Allopathic Medicine)

  • 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 & submission 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.
  • Save the Children & Govt. Hospital:

    Tender  Submission to Save the Children & Govt. Hospital

Assistant Manager, Drug Regulatory Affairs

Get Well Ltd- Pran-RFL Group

May 2016

 

Directorate General of Drug Administration: (Medical Device & Allopathic Medicine)

  • Submission of Recipe for new product licenses.
  • Developing and writing clear arguments and explanations for new product licenses and license renewals;
  • Liaising with, and making presentations to, regulatory authorities;
  • Undertaking and managing regulatory inspections;
  • Negotiating with regulatory authorities about product price for marketing the product;
  • Preparing submissions of NOC (No objection Certificate).
  • To prepare drug clearance for raw material & finished product which release from port.
  • 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

Assistant Manager, Drug Regulatory Affairs

Veritas Pharmaceuticals Ltd

Oct 2017

 

Directorate General of Drug Administration: (Both Allopathic, Narcotics & Herbal Medicine)

  • Evaluation of the proposals of new projects of all systems of medicines from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Recipe for new product licenses according to the DCC
  • Issue and renewal of drug manufacturing licenses (Both Biological & Non-Biological) from Directorate General of Drug Administration (DGDA).
  • Issue and renewal of retail and whole sale drug licenses from Directorate General of Drug Administration (DGDA).
  • Registration and renewal of drug products from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Product Price both IP & MRP Products from Directorate General of Drug Administration (DGDA)
  • Inspection of Pharmaceutical establishments from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Block list (Local & Export) for the import of raw- and packaging materials from Directorate General of Drug Administration (DGDA).
  • Approval of indent for import of finished drugs from Directorate General of Drug Administration (DGDA).
  • Submission, Surveillance and Pharmacovigillance activity from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate & CPP (Certificate for Pharmaceutical Products.) from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Dossier for Export of Medicine from Directorate General of Drug Administration (DGDA).
  • Herbal Medicine:
  • Prepare, Submission & Approval of Herbal Project Profile from Directorate General of Drug Administration (DGDA).
  • Trade Mark:
  • Trade Mark & Registered Trademark approval from Department of Patents, Designs & Trademarks (DPDT)
  • Narcotics:
  • Narcotics License & Drugs approval from Narcotics Department
  • Toll Manufacturing Work:

    All types of Toll Manufacturing activities

Deputy Manager, Drug Regulatory Affairs

SUNMAN-BIRDEM Pharma Ltd

Present

 

Directorate General of Drug Administration: (Allopathic Medicine)

  • Evaluation of the proposals of new projects of all systems of medicines from Directorate General of Drug Administration (DGDA).
  • Issue and renewal of drug manufacturing licenses (Both Biological & Non-Biological) from Directorate General of Drug Administration (DGDA).
  • Issue and renewal of retail and whole sale drug licenses from Directorate General of Drug Administration (DGDA).
  • Registration and renewal of drug products from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Product Price both IP & MRP Products from Directorate General of Drug Administration (DGDA)
  • Inspection of Pharmaceutical establishments from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Online Block list both online & software (Local & Export) for the import of raw- and packaging materials from Directorate General of Drug
  • Administration (DGDA).
  • Approval of indent for import of finished drugs from Directorate General of Drug Administration (DGDA).
  • Submission, Surveillance and Pharmacovigillance activity from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate & CPP (Certificate for Pharmaceutical Products.) from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Marketing Authorization Certificate from Directorate General of Drug Administration (DGDA).
  • Submission & Approval of Product Information Dossier (PID) according to WHO Guideline from Directorate General of Drug Administration (DGDA).
  •  

    Trade Mark:

  • Trade Mark & Registered Trademark approval from Department of Patents, Designs & Trademarks (DPDT)
  • Narcotics:
  • Narcotics License & Drugs approval from Narcotics Department
  • Toll Manufacturing Work:
  • All types of Toll Manufacturing activities
  • Bangladesh Energy Regulatory Commission (BERC)::
  • Submission to the License waiver document from Factory engineering documents
  • Environment Department:

    NOC from Environment Department both online & off line.

 

Education

 

Secondary School Certificate Examination (SSC)

San Jose State University

Jul 2003

 

1. Subject: Science

2. GPA : 4.13 (Out of 5.00)

3. Year of Passing : 2003

Higher Secondary Certificate Examination(HSC)

Northeastern University

Sep 2005

 

 

  1. Subject: Science
  2. GPA : 3.90 (Out of 5.00)
  3. Year of Passing : 2005

Bachelor of Pharmacy (B.Pharm)

Arizona State University

Aug 2012

 

  1. Subject : Pharmacy
  2. CGPA 3.15 (out of 4 )
  3. Year of passing : 2012

Master of Pharmacy (M.Pharm)

University of South Florida

Nov 2014

 

1. Subject : Pharmacy (General)

2. CGPA : 3.35 (Out of 4.00)

3. Year of Passing : 2014

 

Project

 

Survey on awareness of Calcium & Vitamin D among college going students in Bangladesh.

Survey

Jul 2012

 

Survey on awareness of Calcium & Vitamin D among college going students(About 23 College) in Bangladesh.

Tamarindus indica: Potential for treatment of Rheumatoid Arthritis

My M.Pharam Project work

Nov 2014

 

Tamarindus indica: Potential for treatment of Rheumatoid Arthritis

 

Languages

  • English
  • French
  • Arabic
  • German

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What is the Role of a Tender & Regulatory Executive Officer?

In today’s competitive business landscape, the role of a Tender & Regulatory Executive Officer is paramount. This position is a unique blend of strategic thinking, meticulous attention to detail, and a deep understanding of both tender processes and regulatory frameworks. But what exactly does a Tender & Regulatory Executive Officer do? Let’s dive in.

A Tender & Regulatory Executive Officer is responsible for managing and overseeing the tendering process within an organization. This involves preparing tender documents, evaluating bids, and ensuring that the organization complies with all regulatory requirements. Additionally, they liaise with regulatory bodies, ensuring that the organization’s operations align with current regulations and standards. Their role is pivotal in securing new business opportunities and ensuring operational compliance.

What are the Tender & Regulatory Executive Officer Job Requirements?

Embarking on a career as a Tender & Regulatory Executive Officer requires a specific set of skills and qualifications. Here’s a closer look at the essential requirements for this role:

  • A Bachelor’s degree in Business Administration, Law, or a related field.
  • Profound knowledge of the tendering process and regulatory frameworks relevant to the industry.
  • Experience in preparing and evaluating tender documents.
  • Strong analytical and negotiation skills.
  • Excellent written and verbal communication abilities.
  • Ability to stay updated with changing regulatory norms and adapt accordingly.

Additional certifications in procurement or regulatory compliance can further enhance one’s profile in this field.

What are the Responsibilities of a Tender & Regulatory Executive Officer?

The role of a Tender & Regulatory Executive Officer is multifaceted, encompassing a range of responsibilities. Here are some of the core duties associated with this position:

  • Overseeing the entire tendering process, from document preparation to bid evaluation.
  • Liaising with regulatory bodies and ensuring organizational compliance with industry standards.
  • Staying updated with changes in regulations and implementing necessary changes in operations.
  • Collaborating with various departments to gather information for tender documents.
  • Conducting risk assessments related to tenders and regulatory compliance.
  • Providing training and guidance to staff on tendering procedures and regulatory changes.

Each responsibility underscores the importance of this role in securing business opportunities and ensuring smooth operations.

Tender & Regulatory Executive Officer Resume Writing Tips

Creating a compelling resume is crucial for landing your dream role as a Tender & Regulatory Executive Officer. Here are some tailored tips to help you craft a standout resume:

  • Highlight your experience in managing tender processes, detailing specific projects or bids you’ve overseen.
  • Detail your interactions with regulatory bodies and your role in ensuring organizational compliance.
  • Include any training or workshops you’ve conducted or attended related to tendering or regulatory compliance.
  • Emphasize your analytical and negotiation skills with real-world examples.
  • Personalize your resume for the specific role, ensuring alignment with the job description.

Tender & Regulatory Executive Officer Resume Summary Examples

Your resume summary provides a snapshot of your career, encapsulating your experiences and skills. Here are some examples to inspire your own summary:

  • “Dedicated Tender & Regulatory Executive Officer with over 8 years of experience in managing tender processes and ensuring regulatory compliance. Proven track record in securing business opportunities and navigating complex regulatory landscapes.”
  • “Experienced Tender & Regulatory Executive Officer with a keen eye for detail. Adept at liaising with regulatory bodies and leading cross-functional teams in tender preparations.”
  • “Proactive Tender & Regulatory Executive Officer with a passion for driving business growth through effective tender management and regulatory adherence. Known for strategic thinking and meticulous execution.”

Create a Strong Experience Section for Your Tender & Regulatory Executive Officer Resume

Your experience section is the cornerstone of your resume. Here are some examples to guide you in detailing your journey:

  • “Managed a team of 5 in preparing and evaluating tender documents for a multi-million dollar project, resulting in a 20% increase in business opportunities.”
  • “Liaised with regulatory bodies, ensuring 100% compliance in all organizational operations over the past 3 years.”
  • “Implemented a new software system for tracking and managing tender documents, improving efficiency by 30%.”

Sample Education Section for Your Tender & Regulatory Executive Officer Resume

Your educational background lays the foundation for your career. Here’s how you can list your academic achievements:

  • Master of BusinessAdministration, Harvard Business School, 2018
  • Bachelor of Law, Stanford University, 2015
  • Certification in Procurement Management, Procurement Certification Institute, 2017

Tender & Regulatory Executive Officer Skills for Your Resume

Soft Skills:

  1. Leadership
  2. Strategic Thinking
  3. Communication
  4. Problem-solving
  5. Adaptability

Hard Skills:

  1. Tender Management
  2. Regulatory Compliance
  3. Negotiation
  4. Risk Assessment
  5. Document Preparation

Most Common Mistakes to Avoid When Writing a Tender & Regulatory Executive Officer Resume

Your resume is your ticket to your dream job. Avoid these common mistakes to ensure it stands out:

  • Using a generic template. Customize your resume to reflect your unique journey and skills.
  • Overloading with jargon. Keep it clear and concise.
  • Ignoring achievements. Showcase your accomplishments, not just your duties.
  • Forgetting to proofread. Ensure your resume is free from errors.

Key Takeaways for Your Tender & Regulatory Executive Officer Resume

As you craft your resume, remember to:

  • Emphasize your expertise in both tendering and regulatory compliance.
  • Highlight your leadership skills and your ability to navigate complex processes.
  • Personalize your resume for the specific role, ensuring alignment with the job description.
  • Include real-world examples to showcase your skills and experiences.

Finally, make the most of resources like AI Resume Builder, Resume Design, Resume Samples, Resume Examples, Resume Skills, Resume Help, Resume Synonyms, and Job Responsibilities to create a standout application and prepare for the Tender & Regulatory Executive Officer job interview.

With a well-crafted resume in hand, you’re poised to make a lasting impression and take the next step in your career journey. Best wishes on your job search!