Title - Regulatory Affairs Manager

Duration: 12 Months

Work Location: REMOTE

Job details:

• Ideally need someone with Clinical Regulatory experience for novel medicine (non generic)
• Exp with Regulatory registration submissions, biological license, marketing authoring application in US and EU, global exp plus
• Worked on IND and Clinical trial application outside of US plus

Respond to Health Authority questions

• Someone hands-on on facilitation and coordination of submission team
• Project Manager of all key regulatory individuals, regulatory strategist
• Take regulatory strategy and turn into a tangible plan
• Consolidating deliverables into submission package sent to regulatory operations and sent to FDA or marketing team or external CROs
• Ideally looking for a regulatory project manager
• Oncology exp will be great
• Biologics (small or large molecules) will be helpful

Job Description:

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, whilst leading simple through to more complex regulatory applications and managing procedures through to approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities :

• Understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Providing regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and/or region.
• Review of documents (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures 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 complex submissions throughout the product’s lifecycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.

Minimum Requirements- Education and Experience

• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry or at a health authority or other relevant experience
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of Client Business and processes

Skills and Capabilities :

• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Excellent written and verbal communication skills

Cultural awareness

Thanks & Regards,

Ruchii Mathur

Sr. LifeScience Recruiter

Zenith LifeScience LLC

51 Cragwood Road Suite 306

South Plainfield, NJ 07080

Cell No: (848)8004753

Job Type: Contract

Pay: $80.00 - $90.00 per hour

Schedule:

• 8 hour shift

Supplemental pay types:

• Signing bonus

Experience:

• Project management: 1 year (Preferred)

Work Location: Remote

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