Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Regulatory Manager is primarily focused on Business unit program management. This position is responsible for managing regulatory strategy and practices, to support both premarket authorizations and post-approval activities as well as provide regulatory and strategic assessments to support assigned projects and regulatory compliance throughout the company. Essential responsibilities include:
Regulatory Submissions (CMC): Oversees the preparation and filing of global submissions to regulatory authorities, as well as, for support of client applications;
Provide regulatory decisions with regard to acceptability for submission documents.
Project Support: Provides tactical and strategic regulatory input and guidance on cross-functional teams.
Communicates regulatory policy to internal teams and provide clarity on regulatory expectations and timelines.
Interface with partner organizations, consultants, etc. to ensure regulatory issues are satisfactorily met while protecting proprietary information in relation to submission activities.
Technical Guidance: Utilizes and shares expert knowledge to resolve complex issues; trains and coaches others in regulatory requirements.
Compliance: Assess and communicate regulatory requirements, ensuring activities are in compliance with applicable regulations and guidelines.
Reviewing controlled change request for accuracy and regulatory compliance
Ensures that all outside official communications comply with the appropriate
Strategy Development: Actively contributes to the development and implementation of regulatory strategy and timelines for assigned projects and programs.
Life Cycle Management: Develop and execute project plans for change control, complex projects, new registrations and maintenance of existing licenses world-wide.
Surveillance/Intelligence: Maintains an active engagement with emerging and current regulatory requirements in various jurisdictions.
Interfacing with Authorities: Participate in in discussions and negotiations with regulatory authorities, agents, partners and distributers, as required.
Operations/Systems: Oversee the electronic filing processes for global regulatory submissions. Works with the regulatory agencies to ensure the documents comply with regulatory guidance Financial Management: Administers budget reviews against plans.
Influence/Leadership: Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational.
Bachelor of Arts or Science required. A major in a scientific discipline preferred. Advanced degree desired.
RAC certification preferred.
Minimum of 4 years of regulatory affairs experience in FDA regulated industry required.
2 years of demonstrated leadership experience and the ability to work effectively in a multifunctional team environment. Supervisory and managerial experience desired.
Must have FDA Regulated Industry experience and experience interacting with the FDA and/or other health authorities.
Must of a minimum of 10 years in a pharmaceutical, device or healthcare industry.
Position requires strong organizational, technical writing, and or Regulatory CMC experience.
Proficiency using Microsoft Word and Excel required. Experience using ERP/MRP systems required SAP preferred.
Knowledge of US and International Pharmaceutical and/or Medical Device regulations, standards, policies and guidance documents required.
This position requires the understanding of the product and processes and the associated qualification activities are essential in preparing CMC documentation that support both domestic and international applications.
Experience in reviewing and/or authoring CMC sections related to Regulatory submissions.
Physical Requirements: Ability to lift 20 lbs unassisted, 20/30 corrected near-point vision, and prolonged sitting. Minimal travel required.
Employer will assist with relocation costs.
Internal Number: 17005
About Jubilant HollisterStier
Jubilant HollisterStier LLC, a well established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.
Our Promise: Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.
What can we offer?
A culture that values opportunity for professional growth and development
Highly competitive base pay
Comprehensive medical, dental and disability benefits programs
Group retirement savings program
Health and wellness programs