Posted Date: Sep 23 2019
Job Related Experience:
- 5 -7 years of experience in Regulatory Submission- Initial submissions, Variations, Renewals, for Europe, Rest of the World & US region markets
- Understanding and hands on experience on Product registration dossier/ overall CTD modules, extensive experience onModul-1, Module-2.3, Module-3
- Hands on experience in different types of certificates, declarations and Legalised documents - both QA & RA documents for Pharmaceutical product.
- Exposure in dealing various on-site stake holders.
- Experience in dealing with finished product manufacturing sites, stake holders for arranging technical documents required for regulatory submission.
- High attention to detail.
- Highly developed interpersonal, presentation and communication skills.
- Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Computer proficiency, IT skills, the expertise and ability to work with web-based applications
- High level of flexibility and ability to prioritize work
- With minimal input from manager, executes agreed dossier strategy & manages multiple project assignments simultaneously; dossiers will range in complexity.
- Drive and lead assigned set projects/product portfolios.
- completes data assessment to ensure dossier is fit for purpose.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
- Author, prepare, compile, finalise & coordinate as applicable - Module-1, Module-3 (as applicable signed Module-3 documents) Market Specific Requirements (MSRS) package for regulatory submissions & Organise dispatch of MSRs. Identifies risks associated with submission data and information packages. Arrange samples for various regulatory submissions
- Coordinate and arrange clinical and non- clinical documents (Module-2, Module-4 & Module-5 documents) in liaison with Clinical & non-Clinical stakeholders for regulatory submission
- Identify issues that have business impact with relevant escalation process.
- Liaise with market specific requirements suppliers (manufacturing sites, External Supply QA, LOCs) to obtain documentation in a timely manner.
- Update tracking systems & Ensure appropriate archival of MSR data package
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing firstname.lastname@example.org, so that we can confirm to you if the job is genuine.