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Global Regulatory Maintenance Team Lead

8+ years
Not Disclosed
10 Dec. 13, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Regulatory Maintenance Team Lead
Location: Hyderabad
Job Type: Full-time, Permanent

About Sanofi Consumer Healthcare

At Sanofi Consumer Healthcare, our mission is to empower consumers to take control of their health. With your talent and ambition, we can push the boundaries of healthcare innovation, creating breakthrough products that positively impact consumers worldwide. As the Global Regulatory Maintenance Team Lead within the Scientific Communications/Education team, you will play a critical role in ensuring compliance and driving regulatory excellence.

Main Responsibilities

As the Global Regulatory Maintenance Team Lead, you will be responsible for overseeing a team of regulatory professionals and guiding them towards achieving their regulatory goals. Your leadership will ensure that regulatory activities are aligned with Sanofi's strategic objectives and compliant with all relevant regulations.

  1. Team Leadership & Mentoring:

    • Lead, mentor, and guide a team of regulatory professionals.
    • Allocate resources effectively, manage workloads, and prioritize tasks to ensure deadlines are met and regulatory requirements are fulfilled.
  2. Regulatory Strategy & Management:

    • Develop and implement regulatory strategies for pre- and post-approval activities, including dossier preparation, submission, and lifecycle management.
    • Ensure the team’s activities are compliant with global regulatory standards and internal procedures.
  3. Cross-functional Collaboration:

    • Collaborate with internal stakeholders including clinical, medical, pharmacovigilance, labelling, and CMC teams to ensure comprehensive regulatory submissions.
    • Facilitate effective communication between global and local teams to harmonize regulatory activities.
  4. Process Improvement & Efficiency:

    • Lead initiatives to improve regulatory processes, identify efficiencies, and implement best practices.
    • Monitor industry trends and regulatory intelligence, ensuring the team is up-to-date with the latest global regulatory requirements.
  5. Project Management & Reporting:

    • Oversee regulatory projects from planning to execution, managing risks and engaging stakeholders.
    • Provide regular updates and detailed reports to senior management on regulatory maintenance activities, risks, and opportunities.
  6. Regulatory Compliance:

    • Ensure adherence to global regulatory requirements and internal policies throughout the lifecycle of products.
    • Maintain up-to-date knowledge of global regulations, guiding the team through complex regulatory challenges.

About You

Experience:

  • 8+ years of experience in regulatory affairs within the pharmaceutical or biopharmaceutical industry.
  • Proven leadership and team management experience, including mentoring and developing regulatory teams.

Soft Skills:

  • Strong stakeholder management and communication skills.
  • Negotiation abilities, with a proven track record of influencing and engaging with stakeholders across multiple functions.
  • Excellent organizational and project management skills, with the ability to work effectively in a cross-functional and multicultural environment.

Technical Skills:

  • Deep understanding of global regulatory requirements and maintenance processes.
  • Proficiency in regulatory information management systems and relevant software tools such as Veeva Vault and RIM systems.

Education:

  • Master’s degree in a scientific discipline, regulatory affairs, or a related field.

Languages:

  • Fluent in English (both written and spoken).

Why Choose Sanofi?

  • Career Growth: Sanofi provides numerous opportunities for career development and advancement, whether through promotions or lateral moves, both locally and internationally.
  • Work-Life Balance: Enjoy a competitive rewards package and comprehensive health and well-being benefits, including 14 weeks of gender-neutral parental leave.
  • Impact: Contribute to life-changing innovations in healthcare alongside a passionate, diverse, and supportive team.

Pursue Progress. Discover Extraordinary.

At Sanofi, we’re committed to fostering a diverse and inclusive workplace. We believe that diversity drives progress, and we provide equal opportunities to all individuals, regardless of race, color, religion, sex, nationality, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Discover more about our Diversity, Equity, and Inclusion initiatives at Sanofi.

Watch 'One Day at Sanofi' and check out our commitment to inclusion at sanofi.com.