Regulatory Affairs Manager

Há 6 dias

São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro
Regulatory Affairs Manager Job Description

Johnson & Johnson is seeking an experienced Regulatory Affairs Manager to join our team at J&J Innovative Medicine. As a key member of our regulatory affairs team, you will be responsible for overseeing 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:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Labeling and Artwork:
    • Ensure labeling, packaging, and artwork for regulatory compliance.
    • Maintain up-to-date knowledge of labeling regulations and guidelines.
  6. 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.
  7. 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 in Regulatory Governance including Commercial Quality, Regional Regulatory, and global regulatory.
    • Implement innovative processes and take part in local, regional, and global trade unions discussions.
Qualifications:
  1. Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred including MBA or MD certification.
  2. Robust experience in the pharmaceutical industry with a focus on regulatory affairs.
  3. Solid leadership experience, managing and developing high-performing teams.
  4. Extensive knowledge of regulatory requirements and processes for new product introductions, post-registration variations, labeling, artwork, and change control.
  5. Proven track record in preparing and submitting regulatory dossiers and managing interactions with regulatory authorities.
  6. Strong understanding of local and international regulatory guidelines (e.g., FDA, EMA, ICH, PIC/s, WHO).
  7. Excellent written and verbal communication skills.
  8. Strong analytical and problem-solving abilities.
  9. Challenging processes, procedures, and decisions is expected.
  10. Result-oriented with strong organizational and project management skills.
  11. Advanced English is mandatory.
  12. Spanish is preferred.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our page for information on how to request an accommodation.

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