Regulatorry Affairs Manager

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 https://www.jnj.com/.

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are seeking an experienced and dynamic Regulatory Affairs Manager to join our team at J&J Innovative Medicine.

The ideal candidate will have a solid background and expertise in the pharmaceutical industry, including a robust experience in a leadership role .

In this position, you will oversee the regulatory activities related to new product introduction, line extension and new indication including registration, regulatory intelligence, variations, labeling, artwork, change control, promotional material and overall regulatory processes to ensure compliance with local and international regulations.

Key Responsibilities:
• Leadership:
o Lead and mentor a team of regulatory affairs professionals, providing guidance, performance management, and career development opportunities.
o Foster a culture of collaboration, innovation, and regulatory excellence within the team.
• Regulatory Strategy:
o Develop and implement regulatory strategies to support new product introductions, including pre-submission meetings, regulatory submissions, and interactions with regulatory authorities.
o Provide strategic guidance on regulatory requirements to cross-functional teams during development projects and product lifecycle management.
• Regulatory Submissions:
o Prepare and submit high-quality regulatory dossiers for new product registrations (NDA/BLA) in accordance with regional and international guidelines.
o Manage the preparation, review, and submission of post-registration variations, ensuring compliance with legal and regulatory requirements.
• Post-Registration Activities:
o Oversee post-registration activities such as maintenance of marketing authorizations, labeling updates, and amendments.
o Ensure timely submissions for variations, renewals, and other regulatory processes.
• Labeling and Artwork:
o Ensure labeling, packaging, and artwork for regulatory compliance.
o Maintain up-to-date knowledge of labeling regulations and guidelines.
• Change Control:
o Estab...