Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs (Fixed Term)

Biopharma Asia; Raritan (NJ); Presencial; USD 120.000 - 207.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks a Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA.

The role focuses on implementing regional regulatory strategies for marketed and development products across multiple regions, in a matrix environment, with strong leadership and collaboration across Global and Local Operating Companies.

Formación

• Bachelor's degree with 8 years relevant experience (5 years pharm regulatory).
• Masters/PharmD with 6 years relevant experience (4 years pharm regulatory).
• PhD with 4 years relevant experience (3 years pharm regulatory).
• Breadth of global regulatory affairs experience in global drug development and commercialized products.

Responsabilidades

• Implement regional regulatory strategy and submission plans aligned with R&D, regional and local objectives.
• Represent regions and contribute to regional and global regulatory strategy in cross-functional teams.
• Advise product teams on regional/local requirements and impact of supply chain decisions on registrations.
• Lead Regional Working groups to ensure timely execution and align regional with global deliverables.
• Facilitate tactical implementation at regional level with ongoing communication to regional/global teams.
• Develop regional marketing approval submission plans and prepare submission documents for product life cycle.
• Prepare registration dossiers (iCTD/ACTD) and manage country-specific submission requirements.

Conocimientos

AI Judgement

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Strategic Thinking

Technical Credibility

Educación

Bachelor's degree in Pharmaceuticals

Masters/PharmD

PhD

Herramientas

Copilot

Descripción del empleo

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA for a duration of about 13 months.

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.

Purpose:

This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. This person is responsible for collaborating with the Global and Regional Regulatory Leaders, functional area experts and Local Operating Companies to implement/execute the company’s regulatory strategies for both marketed products and products under development in line with R&D, regional and local business objectives. This person will function in a matrix environment and must exhibit strong leadership skills. Responsibilities include:

You will be responsible for:

• Implementing of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
• Representing the regions and contributes to the regional & global regulatory strategy through participation in product-related teams such as, Global Regulatory Teams, submission teams, Labeling Working Groups, CTA Working Groups, response teams, clinical teams, etc., and provides team leadership where appropriate.
• Advising product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
• Leading the Regional Working groups to ensure timely execution of product objectives and aligns regional deliverables with those of the global teams.
• Facilitating tactical implementation at the regional level and ensures ongoing and effective communications with the regional and global teams on product activities and issues.
• Leveraging TA, strategic, tactical, operational, and procedural synergies and efficiencies across regions.
• Providing regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
• Liaising directly with Local operating companies as needed and apply the understanding of worldwide health authorities and applicability of procedures to the regions to help in the preparation for meetings with regulatory agencies in the regions.
• Overseeing management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
• Developing of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, development of tactical planning and timelines, including submission plans, review and preparation submission documents for the products’ life cycle, and communication to relevant groups.
• Preparing of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies.
• Manageing and tracking country-specific requirements for local submission purposes (e.g. legal and technical documents, RMP).
• Overseeing development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.
• Using Gen AI tools such as Copilot.

Experience and Skills:

Education:

Bachelor's degree with 8 years relevant experience (5 years pharm regulatory), Masters/PharmD with 6 years relevant experience (4 years pharm regulatory), or PhD with 4 years relevant experience (3 years pharm regulatory) required.

Required:

Breadth of global regulatory affairs experience in global drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development) is required.

Pharma Regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience

Demonstrated ability to independently handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required.

Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones

Excellent English verbal and written Communication Skills

Experience in working/leading project teams; demonstrated project management skills is required.

Preferred:

Experience specifically in AP, LA, EMEA countries is desirable.

Good working knowledge of regulations and guidelines related to drug development and registration; Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable.

Demonstrated contribution to drug development projects and implementation of strategies is desirable.

Other

Occasional travel - less than 10%

Eligible for severance.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Preferred Skills:

AI Judgement Integration, Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is :

$120,000.00 - $207,000.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

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

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

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