Regulatory Project Manager

2 weeks ago

india PSC Biotech Full time
Job Description
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 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.

Requirements Bachelor’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.
#LI-JL1
Requirements
Bachelor’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 therapeutic 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. #LI-JL1

  • Manager - Regulatory Affairs

    4 weeks ago

    india Tata Consumer Products Full time

    What are the Key Deliverables in this role ? Financial Outcomes Minimize financial impact of regulatory changes to Business through various actions/choices responses. Identify and optimize financial implications of regulatory components on product, packaging and promotions. Customer Service Independently handle regulatory aspects of specific projects...

  • Project Manager

    4 weeks ago

    india Project Partners Ltd Full time

    Job Description Role: Project Manager x 2Salary:  £475 per day (outside IR35)Location: Hybrid, 1-2 days client site (Yorkshire) as needed, remainder remote or at Project Partners head office (Milton Keynes)Are you an experienced Project Manager with a passion for both exemplar governance AND quality stakeholder management?I'm sure you said "yes" to this...

  • Regulatory Director

    2 weeks ago

    India The Skills Coalition Full time

    Job Description Join Our Team as a Regulatory DirectorAre you passionate about transforming the future of energy? Our client is looking for an innovative and driven Regulatory Director to lead the nuclear licensing process in the Netherlands. In this role, you will report to the Global Head of Licensing and drive the advancement of micro-nuclear power...

  • Regulatory Director

    4 weeks ago

    india The Skills Coalition Full time

    Job Description Join Our Team as a Regulatory Director!Are you passionate about transforming the future of energy? Our client is looking for an innovative and driven Regulatory Director to lead the nuclear licensing process in the Netherlands. In this role, you will report to the Global Head of Licensing and drive the advancement of micro-nuclear power...

  • Deputy Manager- Regulatory Affairs

    2 weeks ago

    India Antal International Full time

    Job Description Looking for a candidate having experience in Regulatory affairs domain for one of the medical equipments manufacturng industry. Roles and Responsibities: Regulatory Compliance: Liaison as required between the corporate international regulatory team, SA & ME Region SSU's and regulators to support SSU and corporate compliance with...

  • Product Manager Regulatory

    1 week ago

    india Overture Rede Private Limited Full time

    Job Description This is a remote position. Essential Duties & Responsibilities• Conduct in-depth research and analysis to stay abreast of emerging federal and state healthcare regulations impacting EHR systems, including ONC HIT Certification criteria, HIPAA, Meaningful Use, and other relevant standards.• Translate complex regulatory requirements into...

  • Regulatory Affairs Manager

    2 weeks ago

    India SurgeWay Biosciences Full time

    Company Description SurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook. Our expertise in...

  • Nuclear Regulatory Director

    1 week ago

    india The Skills Coalition Full time

    Job Description Join Our Team as a Regulatory Director!Are you passionate about transforming the future of energy? Our client is looking for an innovative and driven Regulatory Director to lead the nuclear licensing process in the Netherlands. In this role, you will report to the Global Head of Licensing and drive the advancement of micro-nuclear power...

  • Project Management Intern

    2 weeks ago

    India T S Project Eagle Full time

    Job Description ALTERNATE TITLES PM Intern, Design and MarketingDEPARTMENT DesignCOMPANY Project XREPORT TO CEOWe are looking for bold, adventurous & creative Design and Marketing Project Manager Interns who can keep pace with emerging solutions and novel design trends that will shape the next decade.The ideal candidate has the requisite academic...

  • Regulatory Affairs Specialist

    4 weeks ago

    India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub: About us Responsibilities To contribute to the production of client administrative documents and reports to be included in regulatory submissions Compile, or supervise the compilation of...

  • Regulatory Affairs Specialist

    4 weeks ago

    India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

  • Project Manager

    2 weeks ago

    India PERSOLKELLY India Full time

    · Minimum 7 years of experience in project management, preferably in the pharma industry. · Proficient in project management tools such as Asana, Trello, or Jira. · Knowledge of Veeva Vault and Adobe Creative Suite is a plus · Understanding of regulatory compliance and quality systems in the pharma industry · Ability to analyze data and provide...

  • Project Manager

    4 weeks ago

    India PERSOLKELLY India Full time

    · Minimum 7 years of experience in project management, preferably in the pharma industry. · Proficient in project management tools such as Asana, Trello, or Jira. · Knowledge of Veeva Vault and Adobe Creative Suite is a plus · Understanding of regulatory compliance and quality systems in the pharma industry · Ability to analyze data and provide...

  • Project Management Certification Developer, India

    4 weeks ago

    india Project Management Institute Full time

    Project Management Certification Developer, India India ● Virtual Req #516 Tuesday, May 14, 2024 Are you a dreamer, innovator, thinker and a do-er who believes in contributing to something that makes difference?Pursue your passion. Join PMI. How You’ll Make a Difference The Project Management Certification Developer is a critical role...

  • Project Manager

    4 weeks ago

    India PERSOLKELLY India Full time

    ·       Minimum 7 years of experience in project management, preferably in the pharma industry. ·       Proficient in project management tools such as Asana, Trello, or Jira. ·       Knowledge of Veeva Vault and Adobe Creative Suite is a plus ·       Understanding of regulatory compliance and quality systems in the...

  • Regulatory Pharmacist

    2 weeks ago

    India Paragon Consulting Full time

    Job Description Overview A leading pharmaceutical company is seeking a highly skilled and detail-oriented Regulatory Pharmacist. The primary responsibility of this role is to manage the registration process of pharmaceutical products with The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria.The Regulatory Pharmacist will play...

  • Regulatory Sme

    1 week ago

    India Luxoft Full time

    Remote India, India Other Consulting BCM Industry 02/04/2024 Req. VR-97610 **Project description**: **Responsibilities**: Technical Analysis/Development related to regulatory driven initiatives. To be the Regulatory SME, providing analysis and determining requirements to resolve the issues raised to the team. This would include: Ensure all changes that...

  • Certified Project Manager, Digital

    2 weeks ago

    India T S Project Eagle Full time

    Job Description ALTERNATE TITLES Project Manager, Project LeadDEPARTMENT ProductionCOMPANY Project XREPORT TO CEOWe are looking for an analytical and smart-working professional who has at least 5 years of multiple project management and team handling experience.You will be responsible for the day-to-day management and smooth operation of various digital &...

  • Certified Project Manager, Digital

    4 weeks ago

    india T S Project Eagle Full time

    Job Description ALTERNATE TITLES Project Manager, Project LeadDEPARTMENT ProductionCOMPANY Project XREPORT TO CEOWe are looking for an analytical and smart-working professional who has at least 5 years of multiple project management and team handling experience.You will be responsible for the day-to-day management and smooth operation of various digital...

  • Programme Manager

    3 weeks ago

    india Project Partners Ltd Full time

    Job Description Job Title: Programme Manager / Senior Project ManagerLocation: Hemel Hepstead / Loughborough – Hybrid/Remote (days in office to be confirmed; must be flexible to be on-site as required) Salary: £110,000 pa + benefitsAbout Project Partners: Project Partners is a dynamic and innovative consultancy firm dedicated to enhancing project...