CMCD Individual Contributor

3 weeks ago

Bridgewater, United States PSG Global Solutions Careers Full time

Apply now and our proprietary system will quickly have you in front of a live recruiter.
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?

  • Head of Product Marketing, Commercial Lead

    4 weeks ago

    Bridgewater, New Jersey, United States Cosette Pharmaceuticals, Inc. Full time

    Job DescriptionCosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.The company has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets.Key Responsibilities:Develop...

  • Night Fuel Dispatcher

    2 months ago

    West Bridgewater, United States CS Recruiting Full time

    Our client is New England’s largest petroleum transportation company with ten facilities in five of six New England states, specializes in hauling gasoline, diesel, propane, liquid asphalt, heavy oil, flatbed and cement throughout New England.Night Fuel DispatcherOur client is looking for a Night Fuel Dispatcher to work full time in their West Bridgewater,...

  • Night Fuel Dispatcher

    2 weeks ago

    west bridgewater, United States CS Recruiting Full time

    Our client is New England’s largest petroleum transportation company with ten facilities in five of six New England states, specializes in hauling gasoline, diesel, propane, liquid asphalt, heavy oil, flatbed and cement throughout New England.Night Fuel DispatcherOur client is looking for a Night Fuel Dispatcher to work full time in their West Bridgewater,...

  • Engineer-in-Training - Traffic

    3 weeks ago

    Bridgewater, United States Howard Stein Hudson Full time

    About HSH Do you have the desire to be part of THE go-to engineering and planning firm in Massachusetts? Howard Stein Hudson is that firm and we are expanding! HSH is a team of roadway, structural, site/civil, and transportation engineers, planning experts, and community engagement specialists with offices in Boston, Bridgewater, Chelmsford, and Worcester....

  • Engineer-in-Training - Traffic

    3 weeks ago

    Bridgewater, United States Howard Stein Hudson Full time

    About HSH Do you have the desire to be part of THE go-to engineering and planning firm in Massachusetts? Howard Stein Hudson is that firm and we are expanding! HSH is a team of roadway, structural, site/civil, and transportation engineers, planning experts, and community engagement specialists with offices in Boston, Bridgewater, Chelmsford, and Worcester....

  • Product Manager, Branded Marketing

    3 weeks ago

    Bridgewater, United States Cosette Pharmaceuticals, Inc. Full time

    Description Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in...

  • Associate Vice President

    2 months ago

    Bridgewater, United States Persistent Systems Full time

    Position:Associate Vice President - Cloud & Infra Sales (BFSI)Location: Bridgewater, NJ Experience: Minimum 18+ yearsAbout Persistent:We are a trusted Digital Engineering and Enterprise Modernization partner, combining deep technical expertise and industry experience to help our clients anticipate what’s next. Our offerings and proven solutions create a...

  • Night Fuel Dispatcher

    2 weeks ago

    West Bridgewater, MA, United States CS Recruiting Full time

    Our client is New England’s largest petroleum transportation company with ten facilities in five of six New England states, specializes in hauling gasoline, diesel, propane, liquid asphalt, heavy oil, flatbed and cement throughout New England.Night Fuel DispatcherOur client is looking for a Night Fuel Dispatcher to work full time in their West Bridgewater,...

  • Night Fuel Dispatcher

    2 weeks ago

    West Bridgewater, MA, United States CS Recruiting Full time

    Our client is New England’s largest petroleum transportation company with ten facilities in five of six New England states, specializes in hauling gasoline, diesel, propane, liquid asphalt, heavy oil, flatbed and cement throughout New England.Night Fuel DispatcherOur client is looking for a Night Fuel Dispatcher to work full time in their West Bridgewater,...