Regulatory Affairs Manager, Special Projects (Acquisition & Divestitures) - MedTech

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. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Atlanta, Georgia, United States, Boston, Massachusetts, United States of America, Charlotte, North Carolina, United States, Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, New Brunswick, New Jersey, United States of America, New York, New York, United States, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Regulatory Affairs Manager, Special Projects (Acquisition & Divestitures). The preferred location for this role is Raritan, NJ however Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: The Regulatory Affairs Manager, Special Projects Acquisitions & Divestitures is responsible for leading regulatory strategies, due diligence and execution support for corporate transactions involving the acquisition, licensing, or divestiture of assets, products or businesses. This role ensures regulatory compliance and alignment with applicable global health authority requirements throughout the transaction lifecycle. The selected candidate will ensure the RA A&D Team engages in conversations with global Regulatory Affairs members in the Franchises and Regions to define the path to market for the associated transactions, as required.

You will be responsible for:

• Advice J&J Business Development and other functions on regulatory requirements to enable the successful transfer of assets to or from J&J.
• Develop and execute regulatory strategies and plans for divestitures or acquisition projects.
• Leads Global Regulatory Teams for Medical Device divestitures, and accountable for the overall end-to-end strategy and execution, interfaces with buyers to ensure smooth, compliant and timely transitions of assets.
• Supports negotiations and regulatory clauses in asset purchase, license agreements and/or internal quality plans.
• Represents Global Regulatory Affairs on A&D Project Core Teams, providing strategic considerations for acceleration opportunities and identifying risks and issues needing escalation.
• Partners with Regional and Base Business Regulatory, Business Development, Legal, Finance, Quality, Clinical, Deliver, Supply Chain, GSM/Commercial, Trade Compliance, EHS, and IT in support of A&D projects.
• Partners with Regulatory Regional Teams and RA Business Franchise support functions to ensure alignment of regulatory strategies and milestone plans.
• Manages regulatory project plan, budget and resources related to A&D projects.

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree in Life Sciences, Regulatory Affairs or related field is required.  Advanced Degree strongly preferred.
• At least 8-10+ (6-8 with Advanced Degree) years of related experience in highly regulated industry (pharmaceutical, biotech or medical device) experience is required.
• Proven project management skills are required.
• Proven leadership and communication skills required.
• Experience with international license transfers, product lifecycle management or divestitures and acquisitions highly desired.
• Familiarity with regulatory intelligence tools and databases preferred.
• Background in regulatory operations or submission management strongly preferred.
• Strong analytical skills with the ability to assess regulatory risk and impact.
• Excellent communication and presentation skills.
• Project management skills with experience managing multiple complex initiatives.
• Detail-oriented and well-organized with strong problem-solving skills.
• Ability to work cross functionally and exert influence without direct authority.
• Comfortable operating in fast-paced, confidential and high-stakes environments.
• Ability to work with global, virtual teams in a matrix environment and engage internal and external stakeholders at all organizational levels.
• Ability to develop project strategies and plans for complex situations.
• Process oriented, with strong organizational skills to complement project management for the creation of project plans and other required tracking tools.
• Capability to develop and foster productive relationships across the Regulatory organization as well as with cross-functional partner organizations, buyers and sellers
• Up to 5% travel may be required.

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 and 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, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

The anticipated base pay range is $115,000 to $197,800.

Additional Description for Pay Transparency:

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. http://www.careers.jnj.com/employee-benefits