For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, at Simtra, there is a strong emphasis on quality and continuous improvement. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your role at Simtra BioPharma Solutions:
The Senior Regulatory Affairs Specialist role plays an important role in ensuring the successful implementation of complex global regulatory strategies, assisting clients in obtaining and maintaining marketing authorizations for their products and communicating general regulatory requirements in support of licensing of client products. They are also responsible for reviewing and evaluating technical and scientific data and reports required for local submission in support of products. Additionally, the Regulatory Affairs Principal Specialist serves as a consultant to managers and is responsible for managing regulatory activities relating to a specific global portfolio of products.
To excel in this role, the Senior Regulatory Affairs Specialist should have a good understanding of all aspects and phases of their job. This includes managing submission content/format to ensure high-quality submissions to Regulatory Authorities, owning and maintaining regulatory systems, trackers, and databases, and supporting the Company's position on new and changing regulations, guidance, and standards.
What you'll be doing:
· Develop and execute regulatory project plans.
· Identify and elevate key areas of regulatory risk.
· Maintain regulatory files in a format consistent with requirements.
· 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.
· Support regulatory activities relating to specific projects.
· Prepare and review standard operating procedures.
· Represent or lead Regulatory Affairs in small project teams.
What you’ll bring:
· Bachelor’s degree or country equivalent in a scientific discipline required.
· 2+ years of regulatory affairs experience (or relevant experience).
· Ability to multitask and prioritize.
· Project management skills, managing multiple projects and deadlines.
· Ability to work effectively in a multinational/multicultural environment.
· Ability to identify compliance risks and escalate when necessary.
· Operate effectively in a constantly changing and fast-paced work environment.
· Computer proficiency (Microsoft Word, PowerPoint, MS Projects, Excel, and Outlook, databases, and online research)
· Knowledge of aseptic manufacturing is preferred.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Simtra 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.