Regulatory Affairs Associate III

Open to Remote/Hybrid: Hybrid as per *** BaxFlex policy
Work Schedule: Regular
Length of Contract: 1 year (It might be extended after this for another year).
Interview process: (Teams/Onsite, Length, Rounds, Team involved)- Teams


Top 3-5 Must Have Non-negotiable Skills Required
1. US/FDA drugs experience and regulation knowledge
2. Clear Communication skills
3. Global environment experience
4. Work autonomously
5. Ability to multitask and prioritize


Is a bachelor s degree Required? Yes, see in Job description

How many years of recent experience does this person need to have? Minimum 3, see in job description




Job Title: RA Sr Specialist US drugs
Product: GRL support for Drugs
Need: GRL support to cover team members currently on long term sick leave- Melissa Klesch in long term sick leave and no clear visibility when she can be fully back. Katja Erzen currently working 60%.
Additional workload increase related to Annual reporting in the US, safety changes (CCDS management, deferral support to LRA) and labelling support (labelling content development and review ) for product launch supporting Geoexpansion. Required to support timely launch of medicinal products to avoid business impact
These activities are mandatory to support compliance and keep the products on the market.
Start Date: asap
End Date/Duration: 1 year (It might be extended after this for another year).
Max Bill Rate: I kindly ask you to provide your estimate based on Job title and description provided.
Cost Centre: 1001532020 QUA GD R&D EXPENSES
Business Unit: ITT
Site: Deerfield-USA
Onsite/Remote: on site (preferable)
Working Hours: Full time (40 per weeks)

Essential Duties and Responsibilities. This section contains a list of primary responsibilities of the work. The incumbent will perform other duties as assigned.

With direction, develop and execute regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain regulatory files in a format consistent with requirements and perform MoH submissions
Maintain awareness of regulatory requirements; identify relevant requirements
Participate as an active team member and provide regulatory advice to project teams as required
Respond to questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Support regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and SOP s
Represent or lead Regulatory Affairs in small project teams

Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op


Knowledge of regulations
Scientific knowledge
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Negotiation skills
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate when necessary
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op


Bachelor s degree or country equivalent in a scientific discipline
Minimum of 3 years regulatory experience in drugs within a pharmaceutical company, CRO, or similar organization.
Experience in US/FDA regulations and submissions is required, experience in EU and/ or Rest of the world will be a plus.