CMCD Individual Contributor

18 hours ago

Bridgewater, United States PSG Global Solutions Careers Full time

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The Opportunity
Description
We're looking for a CMCD Individual Contributor, working in Pharmaceuticals and Medical Products industry in Bridgewater, New Jersey, 08807, United States.

Job description:

  • Responsible for renewal activities according to current SOPs and Global Planning for all markets.
  • Coordination with Industrial Affairs for dossier creation.
  • Publishing of dossier with Reg Ops and coordination with GRA
  • Leads for dossier dispatch Creation of any response documents and coordination with all partners for completion Appropriate database management (SHARE, etc.)
  • Annual Reports (US, Brazil, etc.)
  • Variation Tracking with Affiliates
  • Variation Data Entry (SHARE)
  • Change Control assistance as assigned by manager.
  • Support other activities including administrative documents for all submission types.
  • eCTD Application Forms (MRP,CP, etc.)
  • Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA.
  • Assures effective involvement with change control systems.
  • Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies.
  • Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success
  • Global operational experience with a mid/large-size Regulatory CMC and Devices Organization
  • Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues
  • Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences
  • Fluency (oral and written) in English language is strongly recommended
  • Potential to be able to mentor and train other contractors is desirable but not essential
  • Be proficient in the use of databases and tools (Regulatory databases, Excel, Powerpoint, etc.)

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?

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