Manager - Regulatory Submissions Assembly
- Bangalore, India
Site Name: India - Karnataka - Bangalore
Posted Date: Aug 29 2019
- Coordinate, engage & Lead delivery of complex submission packages to agreed schedule and technical specification with stakeholders across GRA, GRPD & Local Operating Companies.
- Check compliance of others' work with requirements and standards as per the market specifications
- Advise and assist customers with more complex or non-routine issues coming out of Assembly work on regular basis
- Support & Lead in setting up of process maps/Guides/QRGs for markets transitioning to implement Assembly process
- Lead the creation and implementation of working practices and procedures aimed at simplifying processes and maintaining quality in Assembly team for various markets.
- Identify risks & Lead in preparing action plans in mitigating the identified risks & issues
- Ensure proper Management oversight procedures are in place (Eg: QC process for quality conformance, check lists etc.) to deliver high quality dossiers to various customers
- Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with Assembly team and handle any other work coming out of them
- Supervise and support the work of Submissions Assembly Associates and Specialists
- Manage HR aspects for a team of direct reports including recruitment
- Generate appropriate metrics and key performance indicators for the team, and use metrics to develop and enhance capability in the CoE
- 8-10 years of experience in Regulatory Affairs or related responsibilities
- Managed an operational/production team of more than 5 people that successfully delivered outputs to time and quality over a sustained period
- Worked within a global organization across different geographical locations
- Successfully performed within a regulated or quality-critical environment
- Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products
- Successful and sustained delivery of a significant number of submission packages including a broad range of submission types across eCTD Markets.
- Team Handling experience is Mandatory.
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.
Back to top