- Location
- , US
- Department
- Legal
- Seniority
- Director
- Education
- Bachelor
- Closing date
- Today
- Source
- iCIMS
Description
Overview
The Director, Regulatory & Compliance Strategy ensures our software products comply with global regulations, manages interactions with regulatory bodies, and represents Waters in industry standard groups. This role requires a deep understanding of regulatory processes, developing compliance strategies, and leading initiatives that enhance Waters’ visibility and credibility in the compliance space.
Responsibilities
- Regulatory Strategy Development: Understand and implement regulatory strategies and roadmaps for our informatics products. Develop comprehensive marketing requirements based on the voice of the customer and regulatory needs.
- Regulatory Compliance: Ensure that all products meet health and safety standards and comply with relevant regulatory requirements. Work closely with regulatory bodies to manage interactions.
- Regulatory Direction & Specification Leadership:Lead the definition of regulatory-aligned product specifications by translating evolving global compliance expectations into actionable product requirements. Actively shape regulatory strategy by anticipating future standards and guiding product development toward differentiated, compliance-forward solutions.
- Customer Education: Educate customers on regulatory compliance features and benefits of Waters’ products to support informed decision-making.
- Technical Advisory: Act as a technical advisor and product-specific information conduit between departments. Provide guidance on regulatory requirements and ensure that all teams are aligned with regulatory strategies.
- Subject Matter Expertise: Become a subject matter expert in the regulated space. Stay updated on industry trends, regulatory changes, and best practices. Provide authoritative guidance and insights to internal teams and external stakeholders.
Qualifications
- Demonstrated expertise in the regulated pharma space, with a track record of staying updated on industry trends and regulatory changes.
- Proven experience in product marketing, regulatory affairs, or a related field within the pharmaceutical industry.
- Strong understanding of regulatory processes and requirements in the pharmaceutical market.
- Excellent communication and interpersonal skills, with the ability to influence and collaborate with cross-functional teams.
- Strong analytical and problem-solving skills, with the ability to develop and implement effective regulatory strategies.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Bachelor's degree in Data or Life Sciences, or a related field, advanced degree preferred.
Skills
Compliance
