Regulatory Affairs Associate

1 week 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 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.

Requirements
  • 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.
#LI-JL1
Requirements
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. #LI-JL1

  • Regulatory Affairs Associate

    6 days 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...

  • Sr. Associate Regulatory Affairs

    2 weeks ago

    india QRC Group, LLC Full time

    Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

  • Regulatory Affairs

    3 weeks ago

    india Integrated Services For Productivity & Validation, Inc Full time

    Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

  • Sr. Associate Regulatory Affairs

    3 weeks ago

    india QRC Group, LLC Full time

    Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

  • Regulatory Affairs Specialist

    3 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...

  • Regulatory Affairs Specialist

    3 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

    3 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...

  • Regulatory Affairs Specialist

    3 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

    1 week ago

    India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...

  • Regulatory Affairs

    2 weeks ago

    india Integrated Services For Productivity & Validation, Inc Full time

    Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

  • Associate - Regulatory Affairs

    4 weeks ago

    india Endo Full time

    Job Description Summary Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. Also can responsible for oral solids (tablets, capsules) or sterile...

  • Regulatory Affairs Specialist

    1 month ago

    india Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

  • Regulatory Affairs Specialist

    3 weeks ago

    india Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

  • Senior Officer-Regulatory Affairs

    2 months ago

    india COLORCON ASIA PRIVATE LIMITED Full time

    Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels Coordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officials Coordinate with Global...

  • Regulatory Affairs Manager

    5 days 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...

  • Regulatory Affairs Manager

    4 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...

  • Regulatory Affairs Specialist

    2 months ago

    India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

  • Regulatory Affairs Specialist

    2 months ago

    india Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

  • Deputy Manager- Regulatory Affairs

    6 days 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...

  • Deputy Manager- Regulatory Affairs

    4 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...