Regulatory Project Manager
3 months ago
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 seeking a highly motivated and experienced Regulatory Project Manager with a strong background in sterile injectables. The position will provide strategic guidance and facilitate seamless collaboration, serving as the central point of contact. Responsible for coordinating resources, tracking progress, ensuring timely deliverables, and leading cross-functional teams to support product development, commercialization efforts, and regulatory requirements for a range of product types.
Remote work is permitted. This position is based in York, PA.
- Lead and manage regulatory projects from initiation to completion, ensuring timelines and milestones are met. Conduct initial assessments for required product portfolio.
- Develop and implement regulatory strategies for a range of drug products, including sterile injectable products.
- Provide guidance and expertise to cross-functional teams during all stages of product development and regulatory requirements.
- Proactively coordinate resource allocation, ensuring timely deliverables are achieved.
- Effectively track all project progress, evaluating and developing timelines, schedules, risks, and objectives. Ensure alignment with internal and external stakeholders and project teams.
- Proactively assess and communicate regulatory risks and opportunities. Identify potential risks, and implement corrective actions as needed.
- Conduct and assist in gap analysis.
- Develop, design, and implement pre-clinical studies and experimental protocols.
- Prepare, review, and submit regulatory documents as needed, including INDs, NDAs, BLAs, MAAs, and amendments/supplements to global health authorities (e.g., FDA, EMA).
- Ensure compliance with applicable regulations, guidelines, and industry standards (e.g., cGMP, ICH, USP).
- Monitor and interpret regulatory requirements and provide updates and guidance to team members and management.
- Serve as the primary contact with regulatory authorities and respond to inquiries and requests.
- Maintain accurate and complete regulatory documentation and project records.
- Ensure proper archiving of regulatory submissions and correspondence.
- Additional responsibilities in order to drive successful project deliverables as required.
RequirementsBachelor’s or advanced degree in related science discipline.
Minimum of 7+ years of experience in regulatory affairs within the pharmaceutical industry, with a focus on sterile injectables.
Advanced knowledge of global regulatory requirements and guidelines.
Proven success in designing and developing pre-clinical studies, experimental protocols and processes, and analytical testing.
Strong knowledge and experience in evaluating drug product stability, compatibility, quality, and efficiency.
Proven experience in managing regulatory submissions and interactions with authorities.
Excellent project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
Strong analytical and problem-solving abilities.
Exceptional communication and interpersonal skills.
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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