Regulatory Start Up Manager

Novotech; New York (NY); On-site; USD 130,000 - 165,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Job summary

A leading biotech firm seeks a Regulatory Start Up Manager in New York to oversee regulatory strategies and ensure project alignment with client expectations. Candidates should possess a degree in life sciences and at least 3 years of experience in regulatory operations. The role involves coordinating with local teams and managing the startup process across regions, offering a salary range of $130k–$165k annually.

Qualifications

• 3+ years experience in CRO or pharmaceutical industry.
• Able to manage in a matrix environment.
• Strong English proficiency.

Responsibilities

• Plan and coordinate regulatory startup activities.
• Oversee execution of regulatory startup for projects.
• Provide updates on regulatory startup progress.

Skills

Project management

Regulatory knowledge

Problem-solving

Presentation skills

Communication skills

Education

Degree in clinical, pharmacy or life sciences

Job description

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This range is provided by Novotech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $165,000.00/yr

About the Role

The Regulatory Start Up Managers (RSM) is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client's expectations.)

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
• Distribute start up related documents to local regulatory start up teams.
  • Oversee customization of core start-up documents to local requirements.
  • Ensure preparation and distribution of core contract and budget templates to applicable team members.
  • Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.
  • Oversee site activation package compilation and approvals.
  • Proactively identify any risks to start up and escalate to Project Manager.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.

Experience and Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• Experience managing start up in more than one country and/or region.
• At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
• Through knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Research

• Industries

  Biotechnology Research and Professional Services

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