Regulatory Compliance Manager

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Almac Group is currently seeking a US State Licensing Manager for our Souderton, PA location. The US State Licensing Manager will support Almac Business Development, Operations and Quality personnel at all global sites in the review and execution of work involving investigational drugs and medical devices to ensure that Almac competencies, current regulatory requirements, and industry best practices are met.  In addition, help ensure Almac Clinical Services internal systems remain compliant with current and future US, EU, and other relevant international regulations by reviewing regulatory publications for new and updated guidelines applicable to Almac operations.  Perform core quality compliance activities including the compilation of compliance and risk assessments, maintenance of site state and regulatory agency licensing, writing/revising of procedures and policies and training of staff on relevant procedures.
 
Responsibilities include but are not limited to:
  • Coordinates and track the review of regulatory publications for new and updated guidelines applicable to Almac operations.  Document these changes through the compilation of appropriate documentation including compliance and risk assessments. 
  • Acts as a point of contact and subject matter expert on regulatory requirements involving investigational drugs and medical devices. Provides communication and training to departments within Clinical Services globally.  Interacts with customers as needed to support their clinical trial obligations. 
  • Coordinates and documents local, state, federal, and foreign regulatory licensing and registration efforts for Clinical Services.  Supports regulatory and state licensing activities for Almac Group organizations.
 
Qualifications:
 
Required Experience / Education:
  • Bachelor’s degree
  • 1-3 years of quality or regulatory affairs/compliance experience within the pharmaceutical, biotechnology, and/or medical device industries.  An equivalent combination of education, experience, and training can be considered.
  • Function and purpose of regulatory compliance within a manufacturing environment
Preferred Experience / Education:
  • Bachelor’s Degree in science or related field1+ Years Almac Quality experience
  • Knowledge and/or experience in pharmaceutical and/or medical device clinical trials.
  • Knowledge of medical device quality system requirements (e.g. 21CFR 820, ISO 13485).
  • Personnel Training
  • Current Pharmaceutical Good Manufacturing Practices
 
 
What can Almac Group offer you?
  • Medical, Vision & Dental benefits from the 1st of the month following start date
  • 20 days PTO per year, accrued monthly following start date
  • 12 holidays per year
  • Company paid Long and Short-term disability along with Life Insurance
  • 401k company contribution
  • Professional development programs/ continuous learning opportunities
 
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing 6,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
 
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all.  Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
 
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
 
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
 
 
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process.  Please email us at [email protected] to request assistance.
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