Provides overall management for Global Regulatory Affairs. Duties include management of the global regulatory aspects of new product development and global supply chain for compliance of products and services across Avantor’s diverse portfolio. Leads efforts to comply with all regulations governing the purchase, storage, sale and transportation of extensive product lines sold by Avantor and its subsidiaries. Establishes and implements short- to mid-term strategies with direct impact on the achievement of Avantor business results. Communicates with senior executive leadership regarding regulatory matters of strategic importance and leads a team of professionals in product, medical device, and trade and transportation compliance.
- Responsible for the supervision of direct reports including the setting of realistic goals, monitoring progress and validation of their proposed path forward to resolve problems.
- Interfaces with other Avantor departments to advise them of the regulatory requirements associated with each department and the changes and/or addition of business they propose to undertake. Analyzes the impact of these changes on Avantor including regulatory compliance, customer satisfaction and Avantor profitability to the extent these parameters are tied to full regulatory compliance.
- Continue to remediate Import/Export controls, including development and global harmonized policy implementation. Review, harmonize, and update regulatory policies to reflect current and best practices, and to fully document Regulatory operations.
- Strategically contribution to standards certification/accreditation, permits, licenses (ISO9001, ISO45001, ISO14001, import licenses, import permit, manufacturing license, BIS certification, etc.).
- Develop Biopharma and Cell & Gene Therapy regulatory capabilities including global product regulatory filings for active pharmaceutical ingredients and excipients expanding customer access to Avantor branded products and securing new long-term revenue.
- Oversight of facility and product regulatory registrations ensuring license to operate, facility buildout within GMP requirements and provide significant innovation potential, growth opportunity and product differentiation. Ensure team delivers on customer commitments and key project milestones for product development.
- Monitors total workload, complexity of changes required and budget to make the best possible use of available resources including existing staff, help, and consultants.
- Recognized as a regulatory subject matter expert monitoring regulatory changes and increase understanding of existing regulations for Avantor’s diverse portfolio of products.
- Bachelor’s degree in chemistry, biochemistry, pharmacology, microbiology or related fields; advanced degree in science or regulatory compliance is preferred.
- Experience with domestic and international regulatory filings and interactions with regulatory authorities required.
- 12-15 years of applicable work experience in biopharma or life sciences regulatory affairs product development, experience with biopharmaceuticals and medical devices required.
- 5-8 years of supervisory and leadership experience. Experience in coaching, mentoring and developing others.
- Demonstrated understanding of Regulatory Affairs processes, both pre- and post-marketing is required.
KNOWLEDGE, SKILLS & ABILITIES:
- Working knowledge of the following regulatory areas highly desirable: FDA compliance for medical devices and drugs. Transportation of hazardous materials such as DOT, IATA and/or TDG. Environmental compliance, such as, EPA hazardous waste disposal or RMP. Security Regulations, such as, CFATS. OSHA Employee Right-To-Know, chemical labeling and MSDS requirements.
- Strong interpersonal skills with the ability to engage others and gain their buy-in on compliance issues in situations where there is no direct line of authority.
- Demonstrated excellent people management skills and ability to assess talent and performance in employees.
- Ability to adapt and adjust priorities in a very dynamic environment.