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Regulatory Affairs Senior Manager (Associate Director) CIS region& Specialty Injectables Pharmaceuticals ECEMEA
Location: Warsaw
RA Senior Manager role responsibility applies to two fields: Regulatory Affairs management for Specialty Injectables Pharmaceuticals across the ECEMEA region and Regulatory Affairs field management for all Baxter portfolios in CIS region.
Regulatory Senior Manager SIP for ECEMEA region role responsibility:
The Regulatory Affairs Manager SIP is responsible for the regional regulatory activities of the Specialty Injectables Pharmaceuticals portfolio across the EMEA region. The SIP portfolio includes the Oncology and Anesthesia portfolio of Baxter ECEMEA. The person in the role will play a liaison role across regional teams to ensure the timely execution of regulatory activities of projects to new acquisitions, New product introductions, and product Variations impacting the SIP portfolio across the ECEMEA region. Working closely with the Global Pharmaceuticals team to ensure alignment, partnership, and execution of the RA plan on time.
What you'll be doing?
- Responsible for tracking, generating, and maintaining the RA project status & information in major submissions as requested.
- Regulatory Liaison between countries RA teams in ECEMEA (SEE, CE, ME, Africa, and Russia & CIS) and global regulatory and other parties including but not limited to external suppliers, Manufacturers, and authorities to ensure project execution on time.
- Regulatory representative for pharmaceuticals portfolio/projects in-scope cross functions and business.
- Perform regulatory gap analysis between country regulatory document requirements versus available documents, identify and flag in case of risk on timelines to customers, and propose solutions where needed.
- Works with ECEMEA countries RA team, and Global RA/Pharma to review and submit Responses to regulatory authorities’ questions and LODs within strict deadlines.
- Map the latest and most valid country submission document requirements and build a registration database for ECEMEA countries.
- Manage end-to-end projects scheduled tasks and RA deliverables including submission in planning, coordinating, and performing regulatory submission development, based upon a detailed knowledge of applicable regulations.
- Identify if there are any risks on RA achievements, prepare of a mitigation plan where needed.
- Manage and report submission updates within defined timelines.
Regulatory Senior Manager ( all Baxter portfolio) for CIS region role responsibility:
- Manage new product registration, renewals, and variations in national and EAEC submission types, including requesting the documents, and coordinating translations into National language
- Coordinate the activities of the third parties (distributors, consultancy companies), that perform new product registration, confirmation of registration/renewals or variation procedures on behalf of Baxter in the territory of CIS to ensure fast and successful registration, renewal or variation processes.
- Participate in RA plan development for new drug registration, renewal or variations and operate by the plan.
- Ensure timely submission of safety and any other PIL variations to Proficient Health Authorities.
- Perform any other regulatory actions with the company`s products by the local regulations.
- Maintain databases (both hard copies and electronic ones) of registration documents following the standard operating procedures of the RA department.
- Manage track changes in regulatory affairs legislation and timely advise cross-functional teams and direct leadership to accurate supply plans and marketing strategies if needed.
- Make sure that all regulatory documents & and activities align with the local regulations.
- Follow corporate procedures to fulfill the requirements of regulatory bodies.
- Review and approve final drafts of Ad Prom materials.
- Participate in meetings with partners of the Company and provide RA input, if needed.
- Plan submissions of PSURs; and prepare all necessary documents for the regular PSUR submissions in CIS countries.
- Provide timely reports on performed activities to the immediate manager as well as financial reports within the timeframes and in a format regulated by the policies of the Company.
- Organize and be responsible for EAEC GMP inspections rendering necessary RA support during them.
Your qualifications:
- Minimum of 5 years regulatory experience, including demonstrated experience in project management and regulatory submissions (drug)
- A clear understanding of EU pharma regulations, and requirements regarding submission content and format is required.
- Sound knowledge of the regulatory environment and requirements in CIS countries.
- Proven project management skills.
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to multitask and manage multiple and changing priorities.
- Strong interpersonal, communication, and presentation skills
- Ability to manage complex projects and timelines in a matrix team environment.
- Highly self-motivated individual and self-starter, independent worker
- Ability to work under pressure and adhere to deadlines
- Ability to work effectively in a multinational/multicultural environment
- Computer proficiency in Microsoft Office required, including Word, Excel, PowerPoint, Project, Outlook, and Visio.
- Fluent command of spoken and written English, speaking Russian is a Plus
What we offer:
- Permanent contract after 3 months of probation time
- MICP - Annual bonus
- PPE program with very attractive conditions available for each employee after 3 months
- Private medical care
- Life insurance
- Employee Stock Purchase Plan (ESPP)
- Holiday allowance and 2 additional days off (conditional)
- Employee referral program
- Birthday day off
- Multisport card
- Cafeteria-style plan
- Workation program
- Attractive office location, next to the PKP Powiśle station
- Working for a global pharma/med tech leader
- Possibilities for development on a personal and professional level
- Friendly atmosphere and equal salary opportunity
Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in person in support of our Mission.
We are an equal-opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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