Senior Regulatory Affairs Associate at Alkermes, Inc.
Posted in Compliance 14 days ago.
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Type: Full Time
Location: Waltham, Massachusetts
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
The primary responsibility of the Senior Regulatory Affairs Associate: Works under supervision to assist in planning, review and preparation of investigational new drugs (INDs), new drug applications (NDAs) and all related annual reports, DMFs, amendments, supplements, and continued maintenance of approved marketed products (MAA s). The Associate will ensure compliance with US and international regulations and guidelines. Other responsibilities may include, but are not limited to:
* Support the compilation, development, submission, and maintenance of worldwide regulatory filings
* Track regulatory project status and informational documents
* Coordinate required documentation in coordination with Product Team or Functional group
* Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
* Ensures company strategy is written clearly and represented in Regulatory documents and submissions
* Prepare and deliver polished presentations in team settings, with management and occasionally senior leadership
* Interfacing with global Regulatory partners and internal cross functional teams
* Attending relevant functional area and project team meetings as required
Minimum Education & Experience Requirements:
* Bachelor s Degree, or equivalent, preferred
* Minimum of 5-6 years Regulatory Affairs or related experience required
Knowledge/ Skills Needed:
* Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA guidances
* Experience with global regulatory submissions (INDs, CTAs, MAAs, DMF s)
* Excellent written and verbal communication skills
* Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects
* Motivated, self-starter, able to work independently with minimal supervision
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.