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Senior Associate, CMC Regulatory, New JerseySenior Associate, CMC Regulatory: My client is a leading specialist Pharmaceutical company, with a broad range of products in a number of therapeutic areas.

They are currently looking for a Senior Associate, CMC Regulatory for their office in New Jersey.The role takes responsibility for a specific therapeutic class of development projects and oversees CMC activities.

More specific responsibilities include preparation of CMC of reg …

Senior Associate, CMC Regulatory, New Jersey Jobs New Jersey

REGULATORY AFFAIRS ASSOCIATE ABOUT THE COMPANY: CorePharma LLC is a fast growing mid-size generic pharmaceutical company with approximately 250 employees, located in Middlesex, New Jersey.

We are a ten year old firm principally in the business of developing, manufacturing, and distributing pharmaceutical products for the United States market.

Position Summary: Primary responsibility to prepare, assemble, review, and/or evaluate eCTD format FDA submissions (ANDAs, amendments …

REGULATORY AFFAIRS ASSOCIATE Job in Middlesex 08846, New Jersey US

Deloitte & Touche LLP (AERS) helps organizations identify and manage both risks and opportunities to improve business performance, strengthen controls, and enhance corporate governance.Our practice combines our knowledge and experience in the areas of financial reporting, risk management, and compliance to help address our clients' most important issues.

We're committed to delivering integrated services with a focus on value and quality.

Governance, Regulatory & Ris …

Life Sciences – Regulatory & Risk Communications Sr. Consultant Job in Boston 02116, Massachusetts US

Regulatory Affairs SpecialistPharmaceutical There is an immediate need for a Regulatory Affairs Specialist with pharmaceutical experience in the northern New Jersey area.

The company needs someone with regulatory experience in pharmaceutical drug development and manufacturing.

Experience with Drug Master Files (DMF), NDA and aNDA submissions, and exposure to both US and international Regulatory Affairs issues involving pharmaceutical products is required.

Additional experience in combination devices or simply medical device RA such as 510k submissions is a huge plus.

This is a strong and growing company with excellent promotability and benefits.

In this role you will have the opportunity to be a part of the product development team working on combination products with engineering and quality professionals on both sides of the device and pharmaceutical regulations to insure products in the pipeline are in compliance.

QUALIFICATIONSBS/BA minimum.

Advanced degrees are a plus.

5+ years experience in Regulatory Affairs of medical devices Experience managing a team of Regulatory Specialist and Associates Drug Master File experienceBroad knowledge of pharmaceutical regulations and standards There is a relocation package available for the right candidate.

Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to john [at] mriatl [dot] com and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.

Please send a link if you are interested in joining my network of 8300+ industry executives on LinkedIn.

Regulatory Affairs – Drug Master Files Job in Mahwah, New Jersey US

Job Description:Regulatory Coordinator IKimberly-Clark, a global health and hygiene leader, and our trusted brands are an indispensable part of life for 1.3 billion people in more than 150 countries. Kimberly Clark has been helping generations of families improve the quality of their lives. We go that extra step to ensure the health of our employees and the environment. We believe in recruiting the best people and putting them in the right jobs so that they can do their best work. For more information about our company, visit us at . Currently, we are seeking a Regulatory Coordinator I for our Roswell, GA location. Summary: This position reports to an Associate Director of Regulatory within the Regulatory Affairs Department. Has responsibility for assisting customers/peers, coordinating project data, and may lead small computer based initiatives and projects. Plans and carries out customer service and project responsibilities with minimal direction following training. May provide technical guidance on computer related issues to fellow team members. The main challenges of this position include knowledge of and navigation through the systems used by Kimberly-Clark worldwide and effectively working with other teams in completion of assigned duties. Responsibilities: Gather, input, compile, and maintain information for regulatory databases and internal regulatory staff. Apply regulatory protocols/methods to ensure activities are in compliance with company standards. Maintains records and documents for established systems that support regulatory references.Gathers data for international and domestic submission purposes as well as maintains databases for ready reference of international and domestic regulatory staff. Applies technical quality and regulatory protocols and methods to ensure activities are in compliance with company standards and regulatory requirements. May be responsible for the Regulatory sharepoint site and publication of latest regulatory information. Qualifications:Basic: – Bachelor’s degree in a related field.- 2 years of work experience in a regulated industry.- Excellent skills in MS Office products.- Highly organized- Excellent skills searching information on the internet.Preferred: – Preferred Bachelor’s degree in Biology or other Science degree.- Preferred computer systems such as SAP, sharepoint, trackwise, project, Business Intelligence and cognos- Strong Reading comprehension skills-Ability to think strategically- Knowledge of Human Anatomy a plus- Strong public speaking or communication skills, presentation skills- Demonstrated ability to work in a successful team environment Other: -Ability to effectively work in teams.- Ability to lift up to 50 lbs-Ability to work a 40 hour week, core hours 8-5pmEqual opportunity employerClick here to apply via the Kimberly Clark Career Opportunity PortalMinimum Education Required: BachelorExpected Travel Time: None

REGULATORY AFFAIRS COORDINATOR Job in Roswell 30075, Georgia US