Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Regulatory Affairs Project Manager.
Colombia Jobs Expertini

Urgent! Regulatory Affairs Project Manager Job Opening In WorkFromHome – Now Hiring Freyr Solutions

Regulatory Affairs Project Manager



Job description

About the Company

Freyr Life Sciences; The Largest Global Regulatory Solutions & Services Provider, Supporting, Large, Mid & Small global Life Sciences companies, (Pharmaceutical | Generics | Medical Device | Consumer Healthcare | Cosmetics | Biotechnology | Chemicals | Biosimilar | Biocides) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc.

to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related function.

Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Global Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, Medical Devices, Pharmaceutical, Biotechnology, Biosimilar, Cosmetics, Consumer Healthcare, OTC, Regulatory Intelligence, food supplements, Global Regulatory Affairs, Labeling, Artwork, chemicals, eCTD, and Regulatory software solutions

Job title: Regulatory Project manager - US Submissions experience Mandatory

Job Type: Permanent/Full-time/Indefinite

Work Location: Bogota, Colombia (Remote)

Description:

Experience: 8 - 15 years

Responsibilities

  • Independently manages submissions (and supports internal RPM in managing initial major global filings).

  • Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplements
  • Work with functional sub-teams to develop timeline based on data availability and other critical path activities.

    Identify critical path to submission.

    Maintain timeline during project lifecycle.

  • Schedule kick off meeting.

  • Ensure appropriate representation from needed cross-functional team members.

  • Create draft agenda with GRL/EMRL or Reg Lead and work with cross-functional team to gather presentations.

    Provide agenda for kick off prior to meeting.

  • Facilitate Kick Off.

    Represent Project Management at Kick Off (i.e., present timelines, SWG overview, other slides as needed).

  • Send call for agenda prior to meeting.

    Collect agenda topics from team members and prepare draft agenda for review with GRL/Reg Lead.

    Collect team member presentations for meeting.

    Send agenda to team at least 1 day prior to meeting.

  • Keep team on track and hold team members accountable to represent function.

  • Send meeting minutes to team for input and save final minutes to InterACT
  • Record and track action items.

    Record decisions made and document in decision log for major decisions.

    Record risks raised by team members in risk log, escalate to GRT for major risks.

  • Create and maintain submission timeline in Project Plan.

    Confirm RPP is updated as necessary.

    Identify and raise potential resource constraints to GRL/Reg Lead based on timeline.

  • Maintain SWG InterACT site.

  • Create and distribute dashboard for SWG.

  • Perform scenario planning to identify possible outcomes based on identified risks.

  • Attend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignment.

  • Ensure any incomplete documents identified in doc plan have a timeline that is being tracked in overall submission timeline.

  • Create doc plan/content plan in collaboration with functional sub-teams.

    Confirm adequate time allowed for publishing.

    Maintain doc plan/content plan to ensure timely hand-off of final documents from functional sub-teams.

  • Initiate and manage rapid response team for agency questions, including creation of timeline.

    Ensure plan is in place and communicated for authoring, reviewing, and approving responses.

  • Support internal RPM in preparations for Advisory Committee, if necessary
  • Schedule Kickoff and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation.

    Document decisions & action items
  • Manage authoring, reviewing and approval process for regulatory owned documents as necessary.

  • Schedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA Meetings
  • Populates Content Plan Template with specifics for submission and metadata.

  • Conduct Lessons Learned sessions and capture lessons in lessons learned log.

  • Microsoft Project Management Tool / Smartsheets experience is preferred
  • Computer literacy required in Microsoft Office Products such as Word, Excel, and Outlook
  • Ability to multitask and prioritize competing agendas
  • Fluency in English (written, verbal, reading).

#J-18808-Ljbffr


Required Skill Profession

Asuntos Legales



Your Complete Job Search Toolkit

✨ Smart • Intelligent • Private • Secure

Start Using Our Tools

Join thousands of professionals who've advanced their careers with our platform

Rate or Report This Job
If you feel this job is inaccurate or spam kindly report to us using below form.
Please Note: This is NOT a job application form.


    Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


  • Real-time Regulatory Affairs Jobs Trends in WorkFromHome, Colombia (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Regulatory Affairs in WorkFromHome, Colombia using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 239 jobs in Colombia and 160 jobs in WorkFromHome. This comprehensive analysis highlights market share and opportunities for professionals in Regulatory Affairs roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

  • Are You Looking for Regulatory Affairs Project Manager Job?

    Great news! is currently hiring and seeking a Regulatory Affairs Project Manager to join their team. Feel free to download the job details.

    Wait no longer! Are you also interested in exploring similar jobs? Search now: .

  • The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Freyr Solutions adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:
    • 1. Independence
    • 2. Loyalty
    • 3. Impartiality
    • 4. Integrity
    • 5. Accountability
    • 6. Respect for human rights
    • 7. Obeying Colombia laws and regulations
  • What Is the Average Salary Range for Regulatory Affairs Project Manager Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in WorkFromHome. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

  • What Are the Key Qualifications for Regulatory Affairs Project Manager?

    Key qualifications for Regulatory Affairs Project Manager typically include Asuntos Legales and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

  • How Can I Improve My Chances of Getting Hired for Regulatory Affairs Project Manager?

    To improve your chances of getting hired for Regulatory Affairs Project Manager, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

  • Interview Tips for Regulatory Affairs Project Manager Job Success
    Freyr Solutions interview tips for Regulatory Affairs Project Manager

    Here are some tips to help you prepare for and ace your job interview:

    Before the Interview:
    • Research: Learn about the Freyr Solutions's mission, values, products, and the specific job requirements and get further information about
    • Other Openings
    • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
    • Dress Professionally: Choose attire appropriate for the company culture.
    • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
    • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
    During the Interview:
    • Be Punctual: Arrive on time to demonstrate professionalism and respect.
    • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
    • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
    • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
    • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
    • Follow Up: Send a thank-you email to the interviewer within 24 hours.
    Additional Tips:
    • Be Yourself: Let your personality shine through while maintaining professionalism.
    • Be Honest: Don't exaggerate your skills or experience.
    • Be Positive: Focus on your strengths and accomplishments.
    • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
    • Turn Off Phone: Avoid distractions during the interview.
    Final Thought:

    To prepare for your Regulatory Affairs Project Manager interview at Freyr Solutions, research the company, understand the job requirements, and practice common interview questions.

    Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Freyr Solutions's products or services and be prepared to discuss how you can contribute to their success.

    By following these tips, you can increase your chances of making a positive impression and landing the job!

  • How to Set Up Job Alerts for Regulatory Affairs Project Manager Positions

    Setting up job alerts for Regulatory Affairs Project Manager is easy with Colombia Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!