Senior Project Manager, Regulatory Affairs

Veristat, LLC; Massachusetts; Remote; USD 128,000 - 144,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat, LLC in Massachusetts seeks a Senior Project Manager, Regulatory Affairs to lead and coordinate regulatory programs across CMC, quality, regulatory, clinical and business areas, interfacing with sponsors and vendors to ensure high-quality project execution. The role requires collaboration with internal departments and company leadership, as well as external sponsors.

Veristat offers a remote-friendly environment with flexible time off, medical insurance, tuition reimbursement and

Qualifications

• 6 to 8 years of regulatory experience in a CRO/pharma company, with minimum 3 years in project management or functional lead roles.
• Excellent written and oral communication and interpersonal skills.
• Proficiency in English (written and verbal).
• Ability to build and lead effective project teams and manage multiple stakeholders.

Responsibilities

• Provide management and leadership to plan, prepare, and execute high quality regulatory projects.
• Interface with internal departments and company leadership, sponsors and vendors.
• Integrate consulting activities across CMC, quality, regulatory, clinical and business teams.

Skills

Regulatory affairs experience

Project management leadership

Communication skills

Interpersonal skills

Education

Bachelor's degree in life/health sciences or related discipline

Job description

Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects. S/he interfaces with internal departments and company leadership, and externally with sponsors and vendors. The Senior Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture - 70% remote workforce, 66% women-led teams Learn more about our core values here!

What we offer:

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

The estimated hiring range for this role is $128 - 144K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

What we look for:

• Bachelor's degree in life/health sciences or related discipline, or equivalent required.
• 6 to 8 years of relevant Regulatory experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management or functional team lead experience required.
• Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.
• Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability are required.
• Good working knowledge of drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines.
• Proficiency in English (written and verbal).
• Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions.
• Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.

Automated Decision Making:

All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Equal Opportunity Employer and Diversity Statement

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace. Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices.

Reasonable Accommodations

Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at [e-mail] or [phone]. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice.