Regulatory Compliance Specialist overseeing compliance for Arc'teryx raw materials and goods. Collaborating across teams to uphold regulatory frameworks and ensure consumer safety with legal standards in focus.
GS
Hybrid Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs
Posted 4 months ago
About the role
- Senior Regulatory Specialist managing regulatory activities across multiple CMC projects within Pharma business. Collaborating with diverse teams and mentoring new members to ensure compliance.
Responsibilities
- Ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.
- Preparing technical documentation for global regulatory changes.
- Responding to Regulatory Agency inquiries.
- Providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
- Collaborating with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, and Contract Manufacturing Organizations.
- Mentoring and training new team members.
Requirements
- Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
- Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Thorough understanding of change management processes and regulatory requirements.
- Attention to detail with an emphasis on accuracy and completeness.
- Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
- Flexible and analytical thinking to independently provide solutions to issues.
- Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
- Excellent written and verbal communication skills in English.
Benefits
- Medical Plan
- Life Insurance
- Employee Retirement Program
- Sport and recreation cards
- Recreation allowance
- Annual bonus
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Head of Compliance at Compass managing enterprise risk, information security, and multi - jurisdictional regulatory compliance. Building compliance frameworks in an exciting high - growth SaaS environment.
Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
Senior Tech Compliance Analyst at Syneos Health responsible for global Technology Disaster Recovery efforts, collaborating with various teams and service providers.
BL
Chief Nuclear Officer serving as the nuclear safety authority for BaRupOn's SMR/MMR programs. Establishing safety frameworks and ensuring regulatory compliance within the organization.
International Trade Compliance Manager overseeing compliance with international trade regulations at Northrop Grumman. Leading a team and managing compliance initiatives across multiple locations in the US.
Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.