Senior Manager (Level 1), Regulatory Affairs CMC

AmerisourceBergen Corporation; Dadri; On-site; INR 4,500,000 - 7,000,000; Full time

Job summary

Cencora seeks a Senior Manager (Level 1) in Regulatory Affairs CMC to lead client projects and regulatory submissions for APAC, India, and Noida. You will guide teams, liaise with health authorities, and ensure timelines and budgets are met while expanding service opportunities.

The role requires strong leadership, 10+ years in life sciences consulting or regulatory affairs, and a track record in managing complex CMC programs with cross-functional teams.

Qualifications

• Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or related field.
• 10+ years of experience in scientific consulting, healthcare, life sciences, or related field.
• 2+ years of experience in a management capacity.
• Certification in clinical research or regulatory affairs preferred.

Responsibilities

• Develop and maintain client relationships and drive service opportunities.
• Participate in regulatory processes to gain MTAs for humans and animals including devices.
• Prepare, review and compile CMC documents for regulatory projects.
• Communicate with clients and health authorities.
• Provide scientific advice and represent clients with health authorities.
• Lead project teams and ensure delivery to budget and KPIs.
• Provide day-to-day operational support for colleagues.
• Oversee project teams; resolve invoicing queries.
• Support on-site regulatory activities for GCS clients.

Skills

Regulatory affairs

CMC expertise

Leadership

Project management

Client relationship management

Communication skills

Strategic thinking

Team mentoring

Regulatory intelligence

Presentations

Education

Bachelor's degree in life sciences

Regulatory affairs certification

Tools

Regulatory databases

Job description

## Senior Manager (Level 1), Regulatory Affairs CMCApply: APAC > India > Noida: Full time: Posted Today: R2615917Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details*** Develop and maintain strong client relationships and help drive opportunities for increased service support to Line Manager.* Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects.* Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects.* Communication with clients and Health Authorities.* Support with scientific advice procedures and representation of clients with health authorities.* Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners.* General guidance (consultancy) of colleagues and clients regarding CMC Services.* Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.* Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise.* Ensure personal leadership in supporting VDC strategy implementation and optimization.* Comply with, maintain and contribute to optimizing internal processes.* Provide day to day operational support for colleagues.* Support with VDC led commercial, marketing and business development activities including proposal input.* Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.* In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.* The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.**Minimum Skills, Knowledge and Ability Requirements*** Ability to translate strategical goals of partnerships/customer or internal projects into tactical goals and implement concrete milestones; ability to define appropriate escalation process.* Structured, analytical, systematic and independent way of working; wide discretion to take action consistent with operating policies; determine priorities.* Lead extensive project reengineering activities and provide consultation related to change management. Proactively identify up/cross selling opportunities. Ensure that the team identifies, documents, and drives resolution for program issues.* Demonstrable ability in leading, mentoring, managing and motivation of staff.* Ability to lead project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones.* Ability to manage internal and external (client) relationships on level of client's department heads; ability to discuss and align mid-term goals of collaboration.* Very good communication skills (written and verbally); proven capability to communicate critical issues and propose appropriate (cross-divisional) solutions to decision makers. Good presentation skills, confident appearance.* English business fluent & local language (as appropriate)..**Qualification:*** Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or a related field, or equivalent experience required. **Experience & Skills:*** 10+ years of experience in scientific consulting, healthcare, life sciences, or a related field required. 2+ years of experience in a management capacity required. Certification in clinical research or regulatory affairs, health economics, outcomes research, or real-world evidence methodologies, or equivalent preferred.