Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Target Pay Rate: 60-81.33/hr **salary will be commensurate with experience
Job Description:
As a Regulatory Affairs Manager in Gaithersburg, MD, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. The Gaithersburg site offers a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and healthy.
Client's vision in Oncology is to help patients by redefining the cancer-treatment paradigm. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated regulatory applications and leading procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
What You'll Do?
Minimum Qualifications:
Preferred Qualifications:
Regulatory Affairs Manager
101 Orchard Ridge Drive North Potomac, MD 20878 US
Posted: 09/12/2023
2023-09-12
2023-10-20
Employment Type:
Contract
Job Category: Regulatory Sciences and Medical Writing
Job Number: 581059
Is job remote?: No
Country: United States
Job Description
Target Pay Rate: 60-81.33/hr **salary will be commensurate with experience
Job Description:
As a Regulatory Affairs Manager in Gaithersburg, MD, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. The Gaithersburg site offers a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and healthy.
Client's vision in Oncology is to help patients by redefining the cancer-treatment paradigm. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated regulatory applications and leading procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
What You'll Do?
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory input and submission delivery strategy of all dossiers and all application types per market and/or region. Reviews response documents, study protocols, PSRs, among others.
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Use and share the best methods during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
- Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more sophisticated submissions throughout the products life cycle from either a global and/or regional perspective.
- Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates including regulatory risks and mitigation strategies to designated partners.
- Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
- Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.
- Provide coaching, mentoring and knowledge sharing within the team and contribute to process improvement.
Minimum Qualifications:
- Relevant BS/BA Degree in Science or related field with 1-3 years of regulatory experience within the biopharmaceutical industry, or at a health authority, or other confirmed experience.
- Experience with global clinical trial applications; planning, submission etc.
- General knowledge of drug development.
- Strong project management skills.
- Leadership skills, including experience leading multi-disciplinary project teams
Preferred Qualifications:
- Led regulatory deliverables at the project level.
- Detailed knowledge of the drug development process.
- Knowledge of AZ Business and processes
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Ready to jumpstart your career in the vibrant North Potomac, Maryland area? This charming region, nestled in Montgomery County, is a hidden gem offering job seekers a unique blend of urban amenities and serene natural beauty. With its proximity to the bustling city of Washington, D.C., North Potomac provides an ideal balance for professionals seeking growth opportunities without sacrificing quality of life. Enjoy exploring the nearby Great Falls Park or catch a show at the Strathmore Concert Hall. Indulge in the diverse cuisine along River Road or take a leisurely stroll through the local art galleries. Whether you're into sports, arts, or outdoor activities, North Potomac has something for everyone. Check out our job listings today and discover the exciting career opportunities waiting for you in this enchanting Maryland locale.
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