- Independently and confidently executes agreed dossier strategy
- Independently manages multiple project assignments (e.g., Variations , Product Expansion dossiers, Renewals, MSRs ) simultaneously; assignments will range in complexity but more complex work is expected
- Independently completes data assessment to ensure dossier is fit for purpose
- Identifies risks associated with submission data and information packages
- Escalates issues with line manager that have business impact
- Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems
- Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications
- Understands internal/external Regulatory environment
- Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK
- Knowledge of worldwide CMC regulatory requirements ( preferred)
- Work experience in an international environment would be an additional advantage
- 5 + Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
- Bachelor's or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
- Attention to detail, excellent organization and time management skills
- Excellent written and verbal communication skills in English
- Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
- Performance with Choice – flexibility in working mode (hybrid between office (2/3 days weekly) and remote work based on employee needs)
- 12 months fix term contract of employment
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
- Opportunity to work within GSK standards and documentation applied globally
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
- Flexible working hours
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Senior Regulatory Specialist - Poznań, Polska - 9605 GSK Services Sp z o.o.
Opis
Market Specific Requirements (MSR) within Global Regulatory Centre is accountable for the delivery of all Market Specific Requirements (MSRs) across Global Regulatory Affairs (GRA) across the lifecycle in support of regulatory submissions for Pharma and Vaccines organization.
The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) in support to various applications. Regulatory Specialist is accountable for delivering MSRs documentation in line with existing business needs, strategies, goals and objectives in order to support GSK's product licenses and new applications worldwide. You will have an opportunity to work closely with GRC's internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRC's goals.
Key responsibilities:
Requirements:
If you do not meet all the requirements for a senior specialist, we will consider you for a specialist position. Do Apply
What we offer
#LI-GSK
#LI-HYBRID
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.
