Senior Manager (Level 1), Regulatory Affairs CMC

Amerisource Bergen; Dadri; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Cencora is seeking a seasoned Regulatory Affairs professional to lead CMC and regulatory projects across human and veterinary products, medical devices, cosmetics, and dietary supplements.

You will manage client relations, coordinate cross-functional teams, ensure regulatory submissions on time, and provide strategic guidance to stakeholders while upholding high standards of quality and compliance.

Qualifications

• Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health or related field.
• 10+ years of experience in scientific consulting or life sciences.
• Minimum 2 years in a management role.
• Certification in regulatory affairs or clinical research preferred.
• Very good communication skills, English business fluent.

Responsibilities

• Develop and maintain client relationships and drive opportunities for service support.
• Lead regulatory submissions including CMC documents and registrations for human and veterinary products, medical devices, cosmetics, and dietary supplements.
• Coordinate project teams and external partners to meet KPIs and ensure timely delivery.
• Provide day-to-day operational support for colleagues and clients.
• Present seminars and share regulatory expertise with clients and colleagues.

Skills

Leadership

Project management

Communication

Regulatory affairs

Change management

Mentoring

Strategic thinking

Education

Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health or related field

Job description

Our 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.

Responsibilities

• 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 members strengths as well as to achieve commitment according project milestones.
• Ability to manage internal and external (client) relationships on level of clients 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).

Qualifications

• Bachelors 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.