Senior Specialist, Regulatory Affairs CMC

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. Apply today!

Job Details

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• 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.
• Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• 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.
• Support with VDC strategy implementation and optimization.
• Comply with and support the maintenance of internal procedures.
• Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address 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.
• Handling of M3 databases
• Compilation / handling of wToCs for renewals / variations
• Drafting of eAFs and country information letters for dispatch packages
• Communication with local affiliates regarding local requirements
• Change assessments according to EU variation guideline
• CMC background preferred, IT affinity, very detail oriented, excellent communication skills
• Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.

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 [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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Skills Required

Sops, regulatory intelligence