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Senior Specialist, Regulatory Affairs (CMC, Biologics)

Cencora -
Noida, Uttar Pradesh

Apply Now

Job details

Full-time

Qualifications

English
Quality management
Bachelor's degree
Communication skills

Full 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. 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 with emphasis on CMC aspects.
Support with preparation, review and compilation of biologics 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 REG strategy implementation and optimization.
Comply with and support the maintenance of internal procedures.
Provide operational insights to support with practice area 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 Practice Area Management 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 REG.

Qualification:

Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.
Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred.

Experience:

4+ years of experience in regulatory affairs in biologics CMC, with focus on IMPD, IND, BLA, MAA writing

Skills:

Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope.
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance.
English business fluent

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

Apply Now

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