Senior Manager, Facilities, Global Regulatory Affairs
Company: GSK Poland
Posted on: February 25, 2021
Senior Manager, Facilities, Global Regulatory Affairs
- Rockville, Maryland
- 277507 Job description Site Name: USA - Maryland -
Posted Date: Jan 21 2021
Are you interested in a regulatory affairs role that allows you to
accelerate regulatory compliance across the globe? If so, this
Senior Manager, Facilities, Global Regulatory Affairs could be an
ideal opportunity to explore.The Senior Manager, Facilities will be
responsible for regulatory submissions, interactions with FDA, and
strategy for various US products (including Covid-AS03 related
assets) regarding manufacturing facilities and equipment.Management
of facilities and equipment matters required for the registration
and life cycle for GSK Vaccine products including definition of the
proper regulatory filing strategy, file preparation & submission
and regulatory authorities' interactions for Assigned
Projects/Sites in which GSK Biologicals vaccines are
manufactured.For US FDA/CBER specific interactions (for instance
submissions, consultations...), will function as the "legal agent"
regarding Facilities, Equipment and Inspections.This role will
provide YOU the opportunity to lead key activities to progress YOUR
career, these responsibilities include some of the following---
- Interact with internal project related teams, for Facilities
related regulatory affairs aspects of a given project on technical
- Participate in project/product-related discussions and provide
strategic, scientific and regulatory affairs input, for Facilities
related aspects of given project on technical aspects.
- Provide input into the asset specific regulatory strategy on a
- Provide support to the GRL via input and/or critical review of
the facilities regulatory documents, Global Regulatory Plan(s)
and/or Key Message Summaries.
- Provide support to the GRL to assure efficient interactions
with the regulatory authorities to achieve on-time approvals of GSK
Vaccines submissions for the asset(s).
- Write/review/approve regulatory submissions before they are
submitted to regulatory agencies, mainly to the US FDA (CBER)
- Assess the regulatory impact of Regulatory Facilities related
Changes pertaining to approved commercial products
- Be aware of changes in regulatory guidelines and their impact
on regulatory strategy for the particular asset(s).
- The job also includes providing support (coaching, mentoring,
lead) to several Managers and Specialists in the team. Why you?
Basic Qualifications: We are looking for professionals with these
required skills to achieve our goals:
- Bachelor's degree in Chemistry, Engineering, Biology, or
- 6+ years significant experience in regulatory affairs or
appropriate relevant experience in scientific function combined
with at least 3 years direct RA experience
- Knowledge and experience in US regulations pertinent to
- Knowledge and experience in CMC/Establishments/GMP/ Equipment
Validations Preferred Qualifications: If you have the following
characteristics, it would be a plus:
- Master's degree in Chemistry, Engineering, Biology, or related
- Pharmaceutical development or regulatory affairs experience
with biologics and vaccines preferred.
- Critically reviewing, while ensuring rigorous scientific
content/quality/compliance, key documents targeting internal or
external key audiences, including but not limited to annual
reports, CBE-30 and Prior Approval Supplements, equipment
validations,briefing documents, key meeting summaries, and BLA and
IND establishment modules.
- Program Management - Identifying and escalating regulatory or
programmatic issues while proposing mitigations strategies and
- Effective time management, ability to clearly identify
priorities and manage multiple tasks
- Excellent organizational skills
- Excellent written and oral communication skills
- Ability to strategize, problem solve and influence
- Experience in providing strategic advice on Facilities in
- Experience in interacting with external organizations
pertaining to regulation of Facilities and QA
- Knowledge and experience in regulatory requirements from a
Global perspective (FDA/EMA/International)
- Experience in QA/CMC strongly desirable
- Clear leadership capability/potential Why GSK? Our values and
expectations--are at the heart of everything we do and form an
important part of our culture.These include Patient focus,
Transparency, Respect, Integrity along with Courage,
Accountability, Development, and Teamwork. As GSK focuses on our
values and expectations and a culture of innovation, performance,
and trust, the successful candidate will demonstrate the following
- Agile and distributed decision-making - using evidence and
applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming
challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in
- Continuously looking for opportunities to learn, build skills
and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative,
motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing
trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial
acumen.*This is a job description to aide in the job posting, but
does not include all job evaluation details.If you require an
accommodation or other assistance to apply for a job at GSK, please
contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or
+1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer
and, in the US, we adhere to Affirmative Action principles. This
ensures that 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/ AgenciesGSK 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
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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.Please note that if you are a US Licensed Healthcare
Professional or Healthcare Professional as defined by the laws of
the state issuing your license, GSK may be required to capture and
report expenses GSK incurs, on your behalf, in the event you are
afforded an interview for employment. This capture of applicable
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information, please visit GSK's Transparency Reporting For the
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Keywords: GSK Poland, Rockville , Senior Manager, Facilities, Global Regulatory Affairs, Executive , Rockville, Maryland
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