Manager, Regional Regulatory Affairs - Cross-Regional Operations and Strategy Support

The Manager, Regional Regulatory Affairs - C-ROSS will reside within Global Regulatory Affairs and provide regional regulatory strategic implementation support for products in one or more therapeutic areas (TAs).  This individual will be 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 individual will function in a matrix environment and must exhibit strong leadership skills.

Principal Responsibilities:

• Implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.

• Represent the regions and contribute to the regional and global regulatory strategy through participation in product-related teams such as, Global Regulatory Teams, submission teams, Labeling Working Groups, Clinical Trial Application (CTA) Working Groups, response teams, clinical teams, etc., and provide team leadership where appropriate.

• Advise product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.

• Lead the Regional Working groups to ensure timely execution of product objectives and align regional deliverables with those of the global teams.

• Facilitate tactical implementation at the regional level and ensure ongoing and effective communications with the regional and global teams on product activities and issues.

• Leverage TA, strategic, tactical, operational, and procedural synergies and efficiencies across regions.

• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.

• Liaise 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.

• Oversee management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.

• Development 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.

• Preparation of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies.

• Manage and track country-specific requirements for local submission purposes (e.g.  legal and technical documents, RMP).

• Oversee development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.

• Be current with using Gen AI tools, such as co-pilot.

Qualifications:

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required.  Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.

• A minimum of 6 years of relevant regulatory experience (3 years in pharmaceutical regulatory) with a Bachelor’s degree; a minimum of 4 years of relevant regulatory experience (2 years in pharmaceutical regulatory) with a Master’s or PharmD degree; or a minimum of 2 years of relevant regulatory experience (1 year in pharmaceutical regulatory) with a Ph.D. degree is required.

• Broad Regulatory Affairs experience across drug development and commercialized products, including experience in a therapeutic area and multiple phases of drug development, is required.

• Global Regulatory Affairs exposure/experience is required.

• Pharmaceutical Regulatory Affairs experience in at least one major geographic region is preferred.

• Experience in Asia Pacific, Latin America and EMEA countries is preferred.

• Demonstrated project management skills required.

• Experience in working/leading project teams is required.

• Demonstrated ability to independently handle multiple projects is required.

• Demonstrated contributions to drug development projects and implementation of strategies is preferred.

• Good working knowledge of regulations and guidelines related to drug development and registration is preferred.

• Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development is preferred.

• Knowledge management skills and experience preferred.

• Must have excellent communication and interpersonal skills.

• Must have strong analytical and organizational skills.

• The ability to work and thrive in a multi-cultural and matrix environment is required.

• The ability to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones is required.

• This position may require up to 10% travel.

#LI-Hybrid

Required Skills:

Preferred Skills:

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 :

$117,000.00 - $201,250.00

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)).

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

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