Regulatory Affairs Scientist

1 month ago

House Springs, Missouri, United States Johnson & Johnson Full time


Johnson & Johnson Innovative Medicine is currently recruiting for a Regulatory Affairs Specialist Contract (8-month contract) to be located in US (Titusville, NJ; Raritan, NJ; Spring House, PA; Horsham, PA) or Canada (Toronto, Ontario). Remote work options may be considered within the countries listed on a case-by-case basis and if approved by the Company.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Regulatory Affairs Specialist will be primarily focused in supporting the GRL and regional/ country Regulatory Leads in the planning and executing of Sponsorship transfer activities of an active Phase 3 program into the Interventional Oncology portfolio. This role will also support regulatory project management activities for JNJ as a whole and other programs if required.

He/she will support the execution of all regulatory filings in the Regions, and countries for the sponsorship transfer ( 25+ countries), ensuring sponsorship transfer packages are in alignment with global HA requirements. This individual will also oversee and QC the transfer of regulatory documentation from the partner into JJIM document and trial management systems.

Primary Duties:

• Assist with development of CORE and individualized country packages to support the sponsorship transition. Ensure that all document components are in place on time, identify and track critical path activities and that these packages are packages are made available to the Regions/Countries in accordance with agreed plans

• Leads project management/core package development for the regulatory sponsorship transitions submission team by aligning with plans, identifying any gaps or issues during execution at countries/regions.

• Understanding submission contents and developing traceability of the documentation migration into our system, helping to transfer our knowledge of the product being transitioned.

• Coordinate, contribute to development, track and review the content of responses to queries from HAs to ensure high quality and timely responses. May include other activities as delegated by the RRL/GRL.

• Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.

• Supports GRT project management needs, if required by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning

• Creates a detailed project plan commensurate with scope in an appropriate planning tool such as MSP to closely manage the critical path and associated analytics.

• Contribute to and coordinate regulatory strategy updates over time; provide context and history to new GRT members/stakeholders. Utilize and embed GRA processes and tools to manage team and facilitate work.

• Individual leadership: motivate colleagues through personal example, and dedication to team goals. Inspire confidence and build group trust. Use emotional intelligence to spot signals others miss. Keep group focused on strategy and goals despite complexity, controversy, or conflict. Build bridges between organizations; turn adversity into opportunities for change and growth. Makes authoritative decisions when required

Qualifications

• A minimum of a Bachelor's degree is required.

• Post-graduate degree in Regulatory related field is highly preferred.

• Post graduate degree in life sciences, or business management is preferred.

• Regulatory certification (RAC) is preferred

• Professional project management certification and/or diploma is ideal.

• At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry is required.

• Experience in planning and management of global regulatory submissions (e.g. NDA, MAA, and lifecycle documents etc.) is required.

• Experience in planning and management of IND/CTA's is preferred.

• Demonstrated understanding of Global Regulatory Affairs processes, both pre- and post-marketing is highly preferred

• Knowledge of regulations, guidelines and regulatory requirements is highly preferred.

• Prior experience as a member of a cross-functional team is required.

• Demonstrated ability to resolve conflict and influence teams without formal authority is required.

• Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position is 88000 to

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  • Employees are eligible for the following time off benefits:
    • Vacation - up to 120 hours per calendar year
    • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
    • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
  • Additional information can be found through the link below.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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