Job Closed

This listing is no longer active.

Manager, Regulatory Lead

Location

United States

Posted

20 days ago

Salary

$130K - $165K / year

Seniority

Lead

Job Description

Manager, Regulatory Lead

Alfasigma

Role Description As we continue to grow, we are seeking a Manager, Regulatory Lead. This position will be located remotely on the east coast (EST) of the United States. Scope of the role: - This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation/maintenance of Regional Regulatory Strategy as part of the Global Regulatory Strategy for no more than one low complexity program/single asset. - The manager works under supervision and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, IND/CTA approval, etc. Your key responsibilities: - Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset. - Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies. - Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements. - Contribute to development of regulatory submission plans. - Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities. - Support product development and lifecycle management activities. - Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies. - Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards. - Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities. Qualifications - Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research. - Experience supporting and/or leading IND/CTA submissions. - Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory). - Strong verbal and written communications skills. - Excellent project and/or program management skills. - Detail-oriented and ability to achieve results across functions and levels. - Ability to work effectively across a highly complex, fast paced, matrix organization. - Proficiency in MS Office Suite. - Learning agility and 'scalability' to take on increasing responsibility as Intercept grows. - Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity. Benefits - Competitive salary range. - Comprehensive benefits. - Extensive opportunities for professional growth and development.

Related Job Pages

More Account Manager Jobs

Full TimeRemoteTeam 1,001-5,000H1B No Sponsor

• Build and maintain strong client relationships as the primary point of contact, proactively communicating expectations, updates, and recommendations. • Assess client needs and develop tailored coverage solutions, including evaluating existing programs and identifying opportunities for additional or enhanced coverage. • Lead the renewal process by preparing, analyzing, and effectively presenting coverage options, benchmarking, loss experience, exposure analysis, and program design alternatives. • Manage the client service calendar, including onboarding, renewals, policy issuance, compliance updates, and delivery of required policy documentation. • Ensure insurance programs comply with applicable federal and state regulations and oversee related compliance activities including policy documentation and regulatory filings. • Liaise with carriers and vendors to negotiate contracts, resolve issues, solicit proposals, and manage policy activity to ensure timely, accurate service delivery. • Oversee new client onboarding in alignment with the Peace of Mind process, including timely C-suite engagement. • Partner with Client Success Specialists and internal teams to clarify data needs, monitor task progress, and maintain consistent, high-quality workflows. • Develop client-facing communication materials, including coverage summaries and client risk reports, and coordinate or conduct renewal meetings. • Maintain high standards of accuracy, timeliness, and completeness in all interactions. • Identify opportunities to improve processes, tools, and workflows, escalating issues to leadership as needed.

United States
Marqeta logo

Junior Account Manager – Contractor

Marqeta

You see a card. We see endless possibilities.™

Account Manager20 days ago
ContractRemoteTeam 501-1,000Since 2010H1B Sponsor

• Supporting the strategic efforts of the POD leader in managing key business accounts. • Managing the collateral feedback and approval process, coordinating reviews across internal stakeholders, incorporating revisions, and ensuring all customer-facing materials receive required sign-off prior to distribution. • Creating monthly customer-centric content to keep the broader organization apprised of customer updates, key metrics, and other information pertinent to the Revenue & Go To Market team. • Supporting the development and delivery of presentation materials in Powerpoint/Google Slides, Word/Google Docs, and Excel/Google Sheets (QBRs, Executive Briefing Decks, process outlines, etc.). • Supporting day-to-day customer management processes.

United States
$55 - $65 / hour
Full TimeRemoteTeam 10,001+H1B Sponsor

• Manage and grow key customer accounts within the Industrial Automation sector in Mexico City. • Develop and maintain strong relationships with customers to understand their business needs and provide tailored solutions. • Identify new business opportunities and collaborate with cross-functional teams to deliver value-added solutions.

Mexico
Absorb Software logo

Mid-Market Account Manager

Absorb Software

LMS technology built to accelerate learning and drive results.

Account Manager20 days ago
Full TimeRemoteTeam 501-1,000Since 2003

• Increase the net dollar retention of your book of business through upsells and cross sells • Negotiate client contract renewals with a focus on increased Annual Recurring Revenue and long-term relationships • Generate and close new for opportunities for ‘land and expand’ within assigned accounts • Generate proposals and other client facing documentation to assist your sales process • Identify and develop meaningful client relationships • Accurately manage and report your sales pipeline monthly and quarterly • Thoroughly understand Absorb subscription models to effectively answer client questions • Participate in team meetings and projects to improve sales processes & sales output • Develop strong internal relationships to support client lifecycle • Keep up to date with latest product releases and training seminars to ensure thorough product knowledge

Australia