Global Regulatory Maintenance Team Lead
Hyderabad, India Permanent Date posted Sep. 05, 2024Job title: Global Regulatory Maintenance Team Lead
- Location: Hyderabad
At Sanofi Consumer Healthcare, our Science Hub mission is to empower our consumers to take Health in their Hands! With your talent and ambition, we can do even more to build our Sciences activities and develop breakthrough innovations for consumers worldwide. Your job, as Global Regulatory Maintenance Team Lead within our Scientific Communications/Education
Main responsibilities:
- 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.
About you
- 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 (e.g., Veeva Vault, RIM systems).
- Education: Master's degree in a scientific discipline, regulatory affairs, or a related field.
- Languages: Fluent in English (verbal and written)
Why choose us?
- 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, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- prevention and wellness 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 wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
PursueProgress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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