Regulatory Project Manager

Innova Solutions is immediately hiring for a Regulatory Affairs Project Manager

Responsibilities

1. Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities associated with development and post-marketing activities

2. Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies

3. Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays

4. Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines

5. Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the portfolio to most effectively support global regulatory pathways

6. Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are fully informed and knowledgeable of activities, progress / delays, and risks / issues

7. Facilitate regulatory filing team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up;

meeting leadership and discussion facilitation experience required)

8. Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

Requirements

1. Bachelor’s or higher degree in a related field with >

3-4 years of experience in regulatory project management, (bio)pharmaceutical project management, and / or related discipline

2. Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development

3. Direct hands on experience managing original Marketing Applications and / or LCM submissions from creation to submission through approval / post-approval

4. Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality

5. Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization and passion for novel project management tool building

6. Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path;

direct experience with OnePager and Veeva Vault RIM is a plus

PAY RANGE AND BENEFITS :

Pay Range* : $45-65k / hr

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS : Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion.

Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Website : https : / / www.innovasolutions.com /

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.

com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.

Innova Solutions (HireGenics / Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.