Regulatory Affairs Manager

18 hours ago

Lenoir, United States Simply Biotech Full time

Regulatory Affairs Manager- Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company? Then we've got the right team for you In this role, you're responsible for the duties listed below.

Immediate opening for a Regulatory Affairs Manager with a biotech company in Lenoir, NC who possesses:

  • Regulatory Affairs Certification is a huge plus
  • 5+ years of related regulatory experience in the biologics and medical device areas
  • Thorough understanding of laws and regulations for the FDA, Health Canada, and ICH guidelines
  • Strong experience with change control and understanding of how to improve those processes
  • Experience with BLA and 510k submissions


FULL DESCRIPTION: The Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department as described in the Major Accountabilities of the Role Profile. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.

The selected candidate will be responsible for:

  • Oversee and manage all Regulatory Affairs activities to ensure the technical accuracy, quality, content and format of all regulatory submissions in the appropriate format (eCTD) to the FDA, Health Canada, USDA, and other regulatory agencies.
  • Lead the preparation, submission and management of regulatory filings such as INDs, BLAs, 510(k)s and/or other market authorization applications for both existing and new products.
  • Assess and address regulatory impact of product and manufacturing changes, including overseeing change control assessments.
  • Plan, coordinate and participate in formal meetings, teleconferences, and written communication with regulatory agencies, ensuring timely responses to requests.
  • Oversee the preparation, review, and submission of all biologic and veterinary prescribing information and product labeling, ensuring compliance with all regulatory requirements.
  • Review and approve promotional and advertising materials, ensuring adherence to applicable laws, regulations, and company policies, including timely submission of materials to regulatory agencies.
  • Provide regulatory strategy guidance to project teams and other departments to support product development and life cycle management.
  • Act as primary liaison between the company and regulatory authorities, including the FDA, Health Canada, USDA and other applicable regulatory agencies.
  • Collaborate with other departments (Quality, R&D, Manufacturing, and Commercial teams) to address product complaints, investigations, and any necessary remediation from a regulatory perspective.
  • Ensure accurate product registration, listing, and maintenance of drug listings (SPL) in accordance with local and global regulatory requirements,
  • Manage the regulatory database and tracking system for submissions and approvals.
  • Monitor changes in regulations, laws, and enforcement activities, and assess their potential impact on company products, recommending appropriate action.
  • Work with cross-functional teams to aggregate safety reports including Periodic Adverse Experience Reports (PAERs) Periodic Benefit Risk Evaluation Reports (PBRERs) and Annual Safety Reports (ASRs)
  • Help with planning and implementing the Regulatory Affairs budget
  • Lead, mentor, and develop regulatory team, ensuring high performance and continued professional growth.
  • Manage goals and objectives of the Regulatory Affairs department to align with overall company objectives/priorities.
  • Regularly review and update Standard Operating Procedures (SOPs) to maintain regulatory compliance and improve operational efficiencies.
  • Assist in planning and implementing the regulatory affairs budget, ensuring efficient allocation of resources in line with department objectives.
  • Prioritize and manage the department's resources to meet regulatory deadlines and strategic goals.

The selected candidate will also possess:

  • Develop and execute comprehensive, cost-effective regulatory strategies on time and to budget.
  • Deliver on-time submissions to government Agencies for compliance with regulatory commitments and lifecycle management of legacy products.
  • Provide timely, high quality management reporting to enable effective decision making, and escalation/resolution of issues.
  • 5+ years of related regulatory experience in the biologics and medical device areas.
  • Regulatory Affairs Certification (RAC) is preferred.
  • Thorough understanding of the laws and regulations for the US FDA, Health Canada, USDA, ICH Guidelines, and any other applicable Agency.
  • Thorough understanding of the eCTD format and submission.
  • Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
  • Ability to think strategically, and to interpret and act upon complex or ambiguous issues.
  • Ability to inspire, motivate, and build the confidence of teams to reach goals, while pushing self and others to achieve results.
  • Demonstrates leadership courage through openness to diverse views, condor in assessing and articulation difficult positions, and willingness to make changes when needed.
  • Demonstrates in-depth understanding of advanced technical/scientific principles that relate to a specific product line.


Salary Range: $135k-150k/yr

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