Massachusetts Green Jobs

Manager Regulatory Affairs - 2406200512W

Description

Employer: Janssen Research & Development, LLC

Job Title: Manager Regulatory Affairs

Job Code: A011.4624

Job Location: Cambridge, MA

Job Type: Full-Time

Job Duties: Provide support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Neuroscience therapeutic area. Prepare IND, NDA/BLA dossier filings and related submissions in eCTD format, including preparing meeting packages and responses to Health Authority (HA) inquiries as delegated by the NARL or GRL. Maintain working knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports (DSURs), IND Safety Reports, PADERs, and PSURs. Perform critical review of submission documents to ensure compliance with regulatory requirements. May provide regulatory input for, and appropriate follow-up to, inspections, audits, and product complaints. Perform due diligence activities for assessment of in-licensing opportunities. Serve as the Regulatory representative on specific multi-discipline teams, including organizing and leading meetings. Provide regional input to the global regulatory strategy. Assist in strategy development and execution by researching regulatory, medical, and competitor information for internal regulatory strategy planning documents and submissions to FDA. Review and interpret related product approval information and current HA guidance and Advisory Committee meetings. Partner with the NARL/GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedent, labeling differences, and neuroscience-specific issues. Stay ahead of current and pending neuroscience approvals and maintain working knowledge of laws, guidance, and requirements related to neuroscience, in addition to general regulatory knowledge. Provide input for Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.

May telecommute.

Qualifications

Requirements: Employer will accept a Master's degree in Pharmaceutical Sciences, Pharmaceutical Regulatory Affairs, or related field and 2 years of experience in the job offered or in a Manager Regulatory Affairs-related occupation.

This job posting is anticipated to close on 7/29/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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

• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-Massachusetts-Cambridge

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Science

Req ID: 2406200512W