Regulatory Strategy Director

Dennis Partners; United States; On-site; USD 220,000 - 250,000; Full time

Benefits offered by this job

Collaborative company culture

Strong cash position

Annual target bonus

Equity

Comprehensive benefits

Job summary

A commercial stage biopharmaceutical company is seeking a Regulatory Strategy Director to develop and implement global regulatory strategies for oncology. This remote role offers a chance to collaborate with health authorities and other cross-functional teams, with a budgeted salary range of $220,000 to $250,000 plus bonuses.

Qualifications

• 10+ years pharmaceutical industry experience including 7+ years in Regulatory Affairs.
• Experience interfacing with health authorities in US and EU.
• Strong knowledge of the drug development process and global submission process.

Responsibilities

• Ensure development and execution of regulatory strategies for oncology products.
• Lead preparation of regulatory submissions like INDs and Marketing Applications.
• Interface with regulatory health authorities and manage health agency meetings.

Skills

Regulatory experience in oncology

Cross functional partnering

Excellent organizational skills

Problem-solving under minimal supervision

Ability to manage multiple projects

Education

Bachelor degree in a scientific discipline

Advanced degree (MS, PharmD or PhD)

Job description

This commercial stage biopharmaceutical company developing an innovative pipeline of precision cancer therapies. They are seeking a Regulatory Strategy Director who can develop and implement global regulatory strategies for assigned oncology assets. You will work closely with FDA and other Health Authorities, and serve as the primary Regulatory interface with Asset Strategy Sub-teams. This company offers remote work arrangements, a strong cash position, and a collaborative company culture. With two approved products and an innovative pipeline, now is an exciting time to join this growing organization!

Responsibilities:

• Ensure the development and flawless execution of regulatory strategies for the assigned projects.
• Serve as a strategic partner for internal cross functional stakeholders both within and external to the regulatory organization.
• Represents the company to regulatory health authorities (FDA and others) for assigned projects and/or indications.
• Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
• Work with cross-functional groups to define contributions to submissions. Partner with a regulatory project manager to lead regulatory submission teams for assigned projects.
• Prepare company team for health agency meetings, as required.
• Serve as the primary interface with Regulatory CROs for coordination and preparation of investigational application submissions.
• Responsible for maintaining a working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
• Prepare, plan and implement new processes and policies to improve efficiency of the Company.

Qualifications:

• Bachelor degree in a scientific discipline required. Advanced degree (MS, PharmD or PhD) preferred.
• 10+ years pharmaceutical industry experience, including 7+ years in Regulatory Affairs roles.
• Must have strong (and recent) Regulatory experience in the oncology therapeutic area.
• Requires innovative clinical drug development experience in the US. Experience in EU, UK or Asia PAC, a plus.
• Experience directly interfacing with health authorities in the US and EU.
• Experience in multiple phases of development is required. Phase 3 experience strongly desired.
• Strong knowledge of the drug development process and global submission process.
• Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.
• Experience working in a complex and matrix environment.
• Cross functional partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
• Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a remote position and the Regulatory Director may need to travel to the NYC office once per quarter. Candidates on the East Coast are preferred.

The budgeted salary range for this position is $220,000 to $250,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.