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Regulatory Affairs Associate
3 months ago
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it's about more than just a job-it's about your career and your future.
Your Role
We are hiring an experienced Regulatory Affairs Associate to join our team in York, PA - remote work is permitted. The Regulatory Affairs Associate will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards. Successful candidates should have a strong background in the pharmaceutical industry and sterile injectable products.
- Assist in the initial assessment and coordination for a range of product types within the pharmaceutical industry, including sterile injectables.
- Assist in the development and implementation of regulatory strategies for new and existing products.
- Collaborate with cross-functional teams, including R&D, clinical, manufacturing, and quality assurance, to gather necessary information for regulatory submissions.
- Prepare, review, and submit regulatory documentation, ensuring timely deliverables. Maintain regulatory documentation, files, and archives.
- Monitor and interpret regulatory requirements and guidelines from global health authorities.
- Assist in evaluating potential risks and conducting gap analysis.
- Support the design and development of pre-clinical studies and experimental protocols.
- Prepare and deliver clear and concise regulatory updates and reports to internal stakeholders.
- Maintain knowledge of current regulatory requirements and anticipate changes in regulations that may impact the company's products.
- Additional responsibilities as required.
- Bachelor's degree in related scientific discipline.
- 2-5 years of experience in regulatory affairs within the pharmaceutical industry.
- Knowledge of regulatory requirements for various drug product types (e.g., small molecules, biologics, combination products, sterile injectables, etc.).
- Strong understanding of global regulatory requirements and guidelines.
- Excellent communication and interpersonal skills.
- Strong problem-solving and analytical skills.
- Excellent attention to detail and commitment to quality.
- Must be able to travel.
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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