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218 Sanofi Jobs
Global Regulatory Maintenance Team Lead
8-13 years
Hyderabad / Secunderabad
1 vacancy
Global Regulatory Maintenance Team Lead
Sanofi
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Oversee and mentor a team of regulatory professionals, providing guidance and ensuring alignment with company goals.
- Allocate resources effectively, manage workloads, and prioritize tasks to meet deadlines and regulatory requirements.
- 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 regulatory standards and internal procedures.
- Collaborate with internal stakeholders such as clinical, medical, PV, labelling, and CMC teams to ensure comprehensive and compliant regulatory submissions.
- Facilitate communication between global and local teams to harmonize regulatory activities and streamline processes.
- Lead initiatives to improve regulatory processes, identify efficiencies, and implement best practices.
- Monitor regulatory intelligence and ensure the team is up-to-date with the latest regulatory requirements and industry trends.
- Manage regulatory projects from planning to execution, including risk management and stakeholder engagement.
- Provide regular updates and reports on project progress, challenges, and outcomes to senior management.
- Prepare and present comprehensive reports on regulatory maintenance activities to senior leadership.
- Communicate regulatory updates, risks, and opportunities to relevant stakeholders.
- Experience : Experience in the Pharmaceutical or biopharmaceutical industry, ideally 8+ years in a regulatory role. Proven leadership and team management skills with a track record of managing and mentoring regulatory teams.
- Soft skills : Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Proven leadership and team management skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment.
- Technical skills : Deep understanding of global regulatory requirements and maintenance processes. Proficiency in regulatory information management systems. Experience with regulatory submissions, eCTD format, and relevant software tools (eg, Veeva Vault, RIM systems).
- Education : Masters degree in a scientific discipline, regulatory affairs, or a related field.
- Languages : Fluent in English (verbal and written)
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact.
- prevention and we'llness programs and at least 14 weeks gender-neutral parental leave.
- Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention and we'llness programs and at least 14 weeks gender-neutral parental leave.
Employment Type: Full Time, Permanent
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