- Provide technical-registration details related to the manufacturing and control of established products as required.
- Ensure that authoring/review/approval activities of post approval variations and response to Health Authorities questions are carried out in a timely manner and in accordance with the GSK procedures.
- Support site registrations and renewals activities as required including the request for certificate for pharmaceutical products (CPP), GMP certificates and Manufacturing and Importation Authorization
- Assure regulatory compliance status for established products (e.g. manufacturing and analytical intsructions /procedures are aligned to registered details)
- Act as point of contact for third party customers to support specific regulatory requests for product maintenance.
- Act as regulatory SME for deviations, CAPAs and change control.
- Participate as SME to internal, third parties and regulatory audits.
- University graduate in scientific disciplines (Pharmaceutical Chemistry and Technology, Chemistry, Pharmacy)
- Previous experience in the pharmaceutical industry in quality roles
- Good knowledge of basic GMP requirements (CFR 21, Eudralex Vol. 4)
- Upper Intermediate English language
- Teamworking
- Time management
- Previous experience in third Parties relationship and regulatory compliance in the pharmaceutical industry Master covering regulatory aspects.
- Strong relationship management building skills, with the ability to interact, influence, and manage multiple and varied business contacts, both internal and external, often with different requirements and goals
- Advanced Intermediate English language
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Regulatory Compliance Specialist - Parma, Italia - 532 GlaxoSmithKline Manufacturing SpA
Descrizione
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage
The Regulatory Compliance Specialist will provide regulatory support for manufacturing and registration of site products.
The successful candidate will be able to support and interact with global regulatory and site functions as well as with Third Parties to ensure compliance with GMP and registered details.
In this role, you will...
Basic Qualifications and Skills:
Preferred Qualifications and Skills:
CLOSING DATE for applications: May, Thursday 23rd.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
