Accede Solutions Inc (accedesol.com)

Manager Regulatory CMC Strategy

Accede Solutions Inc (accedesol.com) United States
Accede Solutions Inc (accedesol.com)

Manager Regulatory CMC Strategy

Accede Solutions Inc (accedesol.com) United States
3 months ago 117 applicants

See who Accede Solutions Inc (accedesol.com) has hired for this role

Responsibilities

  • Demonstrate knowledge of global CMC regulatory requirements and criteria for submission and approval
  • Drive resolution of critical issues while applying balanced judgment to drive crisp decision-making
  • Cultivate relationships with key partners and stakeholders, including R&D, Quality, Local and Regional Regulatory Lines etc., to ensure alignment on regulatory strategy and serve as a technical resource
  • Prepare and deliver high-quality CMC regulatory submissions anticipating contemporary assessor thinking for new registrations, post approval changes, renewals, annual reports, line extensions and queries from Regulatory Authorities according to global filing requirements with some guidance
  • Ensure the integrity of regulatory CMC submissions including review of supporting technical documentation and associated investigations with minimal oversight
  • Drive timely completion of CMC commitments made to regulatory authorities
  • Ensure regulatory conformance and consistency globally in compliance with external regulatory requirements and internal policies, standards, and procedures
  • Execute using established operational processes for delivering the product portfolio
  • Display accountability for delivery of assigned portfolio
  • Prioritize and complete assigned workload, including delivery on submission plans in accordance with timelines for specific projects/products/markets with limited supervision
  • Serve as CMC representative on a core project and manage project activities
  • Mentor colleagues within focused area of expertise and share experiences with the team
  • Contribute to CMC-related projects, initiatives & actions, and maintain compliance with internal training requirements and policies, modeling adherence to client behaviors, values and Principles of Integrity

Qualifications

  • Minimum of a Bachelor's Degree in Science or related discipline Minimum of 6 years relevant pharmaceutical experience
  • A combination of experience and education may be taken into consideration
  • Must include a minimum of 2 years of hands-on CMC authoring experience (initial registrations or post-approval variations)
  • Demonstrated knowledge of pharmaceutical development, commercial lifecycle management and associated cGMP requirements relevant to the assessment of technical and regulatory merits of data needed to support CMC changes and commitments
  • Advanced degree (MS/MSc, PhD, PharmD) Emerging awareness of new scientific or manufacturing technology
  • Advanced skills in written & oral communications Computer literacy with Microsoft Office Suite and Documentum-based applications.

#IND123

  • Seniority level

    Entry level

  • Employment type

    Temporary

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

Referrals increase your chances of interviewing at Accede Solutions Inc (accedesol.com) by 2x

See who you know

Get notified about new Regulatory Manager jobs in United States.

Sign in to create job alert

Similar jobs

People also viewed

Looking for a job?

Visit the Career Advice Hub to see tips on interviewing and resume writing.

View Career Advice Hub