Regulatorry Affairs Manager

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.

Key Responsibilities:

- Leadership:

- Lead and mentor a team of regulatory affairs professionals, providing guidance, performance management, and career development opportunities.
- Foster a culture of collaboration, innovation, and regulatory excellence within the team.
- Regulatory Strategy:

- Develop and implement regulatory strategies to support new product introductions, including pre-submission meetings, regulatory submissions, and interactions with regulatory authorities.
- Provide strategic guidance on regulatory requirements to cross-functional teams during development projects and product lifecycle management.
- Regulatory Submissions:

- Prepare and submit high-quality regulatory dossiers for new product registrations (NDA/BLA) in accordance with regional and international guidelines.
- Manage the preparation, review, and submission of post-registration variations, ensuring compliance with legal and regulatory requirements.
- Post-Registration Activities:

- Oversee post-registration activities such as maintenance of marketing authorizations, labeling updates, and amendments.
- Ensure timely submissions for variations, renewals, and other regulatory processes.
- Labeling and Artwork:

- Ensure labeling, packaging, and artwork for regulatory compliance.
- Maintain up-to-date knowledge of labeling regulations and guidelines.
- Change Control:

- Establish and manage change control assessments to ensure all regulatory changes are documented, assessed, and implemented appropriately.
- Collaborate with cross-functional teams to assess the impact of changes on regulatory submissions and approvals.
- Compliance and Process Improvement:

- Ensure compliance with all relevant regulations, guidelines, and internal SOPs.
- Identify opportunities for process improvements and implement best practices in regulatory affairs.
- Take part of Regulatory Governances including Commercial Quality, Regional Regulatory and global regulatory.
- Implement innovative process and take part of local, regional e global trade unions discussion.

**Qualifications**:

- Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred including MBA or MD certification.
- Robust experience in the pharmaceutical industry with a focus on regulatory affairs.
- Solid leadership experience, managing and developing high-performing teams.
- Extensive knowledge of regulatory requirements and processes for new product introductions, post-registration variations, labeling, artwork, and change control.
- Proven track record in preparing and submitting regulatory dossiers and managing interactions with regulatory authorities.
- Strong understanding of local and international regulatory guidelines (e.g., FDA, EMA, ICH, PIC/s, WHO).
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Challenging processes, procedures and decisions is expected.
- Result-oriented with strong organizational and project management skills.
- Advanced English is mandatory.
- Spanish is preferred.