We are representing a top, global Consulting firm in their search for a Senior Regulatory Attorney, Life Sciences based remotely that will be responsible for providing regulatory legal advice to the Company on global regulatory requirements pertinent to the company services and software products.
Responsibilities:
- Negotiate regulatory terms in service agreements for offerings to life sciencescustomers for services, products and/or platforms, and other tools used insupport of regulated activities.
- Provide legal advice to business clients and commercial attorneys onregulatory requirements related to products and services provided to lifesciences clients.
- Assist in the development of new products and services by identifyingapplicable regulatory requirements.
- Support corporate and business unit compliance staff; designatedcompliance offices in developing and appropriately implementing policies andprocedures; act as internal advisor/consultant; and oversight andmonitoring/reporting activities to ensure compliance with applicable global
- Work with internal business and product teams to determine any applicablelicenses necessary to support the products and/or services provided.
- Identify and mitigate regulatory risk across all life sciences lines of business.
- Manage and help guide the interpretation of global laws and standardsapplicable to the business, and assist and guide the business in implementingrequired changes.
- Review relevant life sciences legal proceedings, court judgments, and caselaw, and apply lessons learned.
- Coordinate and collaborate with life sciences management, business delivery and development teams to ensure awareness of regulations and regulatory expectations relevant to life sciences line of business.
Requirements:
- Strong regulatory background on global laws and regulations such as ICH
- Good Practices (GCP, GVP), MHRA, 21 CFR Part 11/Annex 11 (EU), IEEEand medical device regulations and related guidance; GMP and GAMPexperience a plus.
- Ability to work independently at a senior level with business stakeholders.
- Familiarity with HIPAA privacy and security regulations and GDPR as appliedto life sciences and clinical research data collected at clinical sites globally.
- Proven experience creating and implementing legal strategies and tactics;legal risk management; and contract language for contractors ofpharmaceutical, biologics and/or medical device companies; Intellectualproperty experience a plus.
- Knowledge and experience developing and reviewing contracts, SOWs,Quality Agreements and other agreements to flag and address key regulatoryand compliance requirements.
- Advanced communication skills including ability to communicateprofessionally with regulators, executives, clients and operations staff at alllevels in a fast-paced environment.
- Experience managing multiple direct and indirect reports in a matrixed
- A minimum ten years of experience providing legal advice within the lifesciences industry.
- JD from accredited law school and active bar licensure in at least one state.
Application Process – Qualified professionals are to submit their Resume to Elizabeth Parija at: elizabeth@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
