Role Title: Senior Counsel Regulatory Affairs (US)
Organization: RDS Legal
Location: Pleasanton, Santa Clara, or Indianapolis US.
This is a strategic role aimed to provide proactive guidance and counseling to different groups within the Regulatory Affairs Function across RDS, RIS and RDC, related to US regulatory activities with an eye towards minimizing company legal exposure and ensuring continuous compliance. The role is focused on using legal regulatory frameworks, based on legal interpretation of applicable laws and regulations to maximize business opportunities and build relationships of trust with regulators, including FDA.
The candidate will have a total of 10 to 15 years of experience supporting a Regulatory Affairs organization in the Life Sciences Industry (preferably Diagnostics or Devices), in addition to substantive relevant Regulatory experience in a national law firm directly involving global and US FDA matters or at FDA.
Quality and Regulatory
Quality Issues/Product Safety/Medical Device Reporting/Recall-Related Activities
- Counseling on product label changes and legal issues involved in label changes
- Counseling regarding quality agreements and manufacturing & supplier agreements
- Counseling on regulatory issues relating to the supply chain on a national and international basis
- Guidance on the national requirements for an Authorized Representative, Responsible Person or equivalent
- Guidance related to Dear Doctor letters and other physician communications, including potential legal issues related to these
- Review of SOPs related to Adverse Event Reporting, Complaint handling, corrective actions and Recalls with an eye towards continuous compliance and enhancements
- Counseling on handling of legal and reporting aspects related to regulatory inspections, signal detection and assessment
- Counseling on correspondence with Notified Bodies, Conformity Assessment Bodies and equivalent bodies globally (“Assessment Bodies”)
- Review, input, and approval of regulatory communications and communications / actions to patients or hospitals or customers, including UMDCs, which may impact future legal liability
- Advertising and Promotion Consultation
- Guidance on the application of applicable legislation to digital solutions that may be classified as medical devices
- Strategic legal advice related to timing and content of communications with regulators and Assessment Bodies including:
- Supplements Approved/Cleared Products
- Correction and Removal Reports
- Inspection responses (e.g., responses to FDA Form 483, Untitled Letter, Warning Letter)
- Class I or Class II recalls
- Product classification
- CE Marking and equivalents globally
- Legal support related to life cycle and management strategies, including filing Citizen Petitions, FDA white papers, and comments on key FDA docket issues
- Collaborate with other Roche Regulatory counsel to keep informed and monitor major horizon issues, enforcement trends, and opportunities for company thought leadership on important regulatory issues at FDA, EMA, SwissMedic, and other regulatory agencies globally.
Advertising and Promotion
- Advising on go to market strategy and messaging for healthcare and patient communications for high risk / high visibility products (first to market, highly innovative, products subject to litigation, etc.)
- Legal support for Medical and Scientific Affairs Activities
- Consulting and collaboration with Regulatory teams related to overall compliance trending and training activities
- Counseling on compliance with applicable Industry body codes of practice and other national bodies regulating promotional activities
- Consulting and collaboration in the area of Policy Monitoring through external agencies such as AdvaMed and FDLI
- Review and overview of SOP’s related to Ad/Pro processes / approval / trends etc. from a US perspective including US Based Mfg and LCT’s.
- Coordinate with Compliance on related Ad/Pro issues
- Review of content related to guidance on US Commercial and Medical roles in promotional and scientific communications and support of any escalated issues related to US material in PCAP
US FDA Regulatory Submissions
- Consulting on the appropriate regulatory framework and application type for individual products
- Timing of communication with regulators about changes, and which format to use, including when a new filing is required
- Considering how regulatory communications and actions may impact future legal liability to patients or hospitals, and guiding actions with that in mind
Key Requirements for This Role
- Doctor of Jurisprudence from ABA-accredited law school, licensed to practice law in one or more of the 50 states.
- At least 10 years’ experience practicing law (mostly with a Regulatory Affairs focus); with at least 5 years practicing law at a large to medium sized law firm and at least five years’ experience in a corporate law department of a Life Sciences company, including Pharma/Diagnostic/Medical Device/Biotech companies with direct responsibility for Legal Regulatory Affairs matters and issues.
- Tenure at Roche working with multiple business units/areas or experience representing a company in the Life Sciences sector.
- Extremely well-developed negotiation skills. Ability to appreciate and work in a nuanced environment/navigate difficult areas to achieve successful results.
- Experience managing others directly or indirectly
- Maturity, self-awareness, strength of character, courage, agility and strong business partnership, influencing and collaboration skills. Willingness and ability to deliver a consistent message in the face of adversity.
- A demonstrated ability to establish and maintain open and trusting work relationships and build bridges across different functions and stakeholders.
- 5 years practicing law at a large to medium sized law firm mostly with a Regulatory Affairs focus and 5 years in-house with proven experience handling FDA-related issues, strategy and negotiations in all areas including, submissions, label changes, safety signals, recalls, warning letters, FDA Form 483 issues, etc.