Regulatory Affairs Manager Job at Katalyst Healthcares & Life Sciences, Franklin Lakes, NJ

bFh0V1g5SytsUDBKNHBBd0MvdjgvOWNHREE9PQ==
  • Katalyst Healthcares & Life Sciences
  • Franklin Lakes, NJ

Job Description

Responsibilities:

Provides regulatory leadership to assigned platform teams providing regulatory guidance throughout the product development lifecycle and coordinating team inputs for regulatory submissions.

Works with Associate Director and Platform Leaders to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans

Foster deep regulatory partnership and drive execution of critical customer initiatives

Takes lead regulatory role for new customer engagement with commercial leaders

Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers' regulatory submissions.

Takes a lead role in key business decisions and plan regulatory resources accordingly to ensure the development of an efficient organization and continuously seek for improvements in efficiency.

Identifies and communicates potential risks and mitigations associated with regulatory strategies to partners.

Support to customers for regulatory advice and registration of their products and interact as necessary with the U.S. regulatory agencies and Notified Bodies.

Reviews and/or approves product marketing claims and communication, promotional materials, labelling, clinical protocols and clinical reports.

Conducts training on regulatory issues for staff and for business partners (e.g., Platform, R&D, Marketing and Pharma Partners).

Participates in internal/external trade, professional, and standards development organizations.

Manages multiple projects with minimal supervision.

Requirements:

B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.

Minimum five 5 years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields.

Demonstrated project management, negotiation, and communication (written and oral) skills.

Working knowledge of regulations for medical devices and drug-device combination products.

Understanding of product development cycle, clinical phases, change management and marketing of pharmaceutical products.

Experience with software and digitally connected devices.

Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators.

Ability to resolve problems and to make appropriate regulatory decisions under pressure.

Ability to adapt and respond quickly in a constantly evolving and often ambiguous environment.

Job Tags

Permanent employment,

Similar Jobs

Flik Hospitality Group

GUEST SERVICES AGENT (PART TIME) Job at Flik Hospitality Group

 ...Flik Hospitality Group We are hiring immediately for part time GUEST SERVICES AGENT positions. Location : Babson Executive Conference Center - 1 Woodland Hill Drive, Babson Park, MA 02457. Note: online applications accepted only . Schedule : Part time... 

Southern Glazer’s Wine and Spirits, LLC

Warehouse Manager Nights Job at Southern Glazer’s Wine and Spirits, LLC

 ...If youre looking to fill your glass with opportunity, come join our FAMILY. Overview Responsible for night shift leadership and management in a warehouse with high volume , scope, and complexity. This role will provide overall direction and coordination of... 

Optomi

Jira ITSM Administrator/Engineer (100% Remote) Job at Optomi

Jira ITSM Admin/Engineer (100% Remote)Optomi, in partnership with an industry leading is seeking a Jira expert for a major client. This role will be a remote, contract-to hire opportunity.Responsibilities:Build initial ITSM configuration, Customer ticketing, Automation... 

Walmart Inc.

2025 Summer Undergraduate Intern: Walmart Fashion (USA) Corporate Intern Job at Walmart Inc.

What you'll do at Position Summary... What you'll do... An Apparel Merchandising Internship means an opportunity to explore a career as part of the worlds largest retailer! We are looking for students who are strong problem solvers who can deliver solutions...

Sevita

Caregiver Job at Sevita

 ...lived. OPEN INTERVIEWS Tuesday, November 19th from 9am-3pm Where: 2302 Falls Ave, Waterloo Part-time Days/Overnight(Sleep) Combo Shift Available! THRIVE AS A CAREGIVER AT SEVITA. EACH DAY, YOULL Be proud of rewarding work helping people grow,...