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Associate, CMC Regulatory Affairs (290-419)

ARIAD Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 5/2/2013 Position Type: Full time Job Code: 290 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description



ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary

The successful candidate will primarily provide support for regulatory technical writing activities; will liaise interdepartmentally within ARIAD Pharmaceuticals., Inc., and report to the Director of Regulatory Affairs, CMC. The candidate will be required to have a proficient knowledge base of cGMP requirements and demonstrate an expertise in CMC writing skills.

Responsibilities

- The qualified individual will assist in the preparation and authoring of Module 3, Module 2.3 and/or any other assigned sections for appointed development products.
- This includes Investigational New Drug applications (INDs), IND amendments and/or annual reports and corresponding foreign Clinical Trial Applications (CTAs) that are complete, in compliance with source documentation (batch records, SOPs, reports etc) and in agreement with applicable global regulations.
- In addition, the qualified person will assist in the preparation and authoring of M3, M2.3 and/or any other assigned sections for appointed commercial products. This includes New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), International Marketing Applications (IMAs) and any post approval supplements or reports thereto as required.
- The individual may also assist with development of effective regulatory strategies for global product development, working with line management, as required.
- The responsible person shall also interact with interdepartmental personnel as required and shall prepare interpretive analyses of key regulatory guidance documents, regulations, or directives that impact ARIAD's products and manufacturing operations.
- The qualified person shall contribute to and support QbD approach to process life cycle management and prepare QbD protocols to be the basis of regulatory life cycle management as directed.
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements



- A Bachelor of Science degree in a science related field required
- 2 years industry experience in manufacturing, quality control and/or quality assurance preferred
- Excellent communication and organizational skills as well as keen attention to detail required; the individual shall also be able to demonstrate the ability to work in a team environment
- Experience with MS Word, Excel and MS Project applications necessary
- Strong commitment to business ethics
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.
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