Senior Manager - Regulatory Affairs CMC

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.
• Proven in-depth professional experience in area of responsibility; extensive knowledge of discipline or department, solves complex problems, strong understanding of the business.

.

Qualification:

• University degree in Life Science

Experience:

• 10–15+ years of regulatory affairs experience in the pharmaceutical industry, with strong focus on European markets and post-approval / lifecycle maintenance.

Skills & Knowledge:

• 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

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned