Regulatory Affairs Manager — IND/NDA Submissions (Hybrid)
Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical, Inc. is seeking a Manager of Regulatory Affairs to lead regulatory support for marketed products and development programs. The role requires collaboration with Medical, Commercial, Legal, Compliance, and Technical Operations to file and maintain applications in compliance with applicable regulations. The position focuses on IND/NDA submissions, regulatory publishing, and labeling management, with a mandate to uphold Collegium’s core values and deliver team goals in a #J-18808-Ljbffr Collegium Pharmaceutical, Inc.
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to support regulatory activities for marketed products and development programs. You will work across Medical, Commercial, Legal and Compliance to file and maintain applications in compliance with regulatory...Suggested
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to provide regulatory support for... ...with applicable regulations. Hybrid position in Stoughton, MA, onsite... ...include preparing INDs and NDAs, managing submissions to FDA and other health authorities...Suggested
$132.22k - $158.4k
...Manager, Regulatory Affairs Stoughton, MA Collegium Pharmaceutical is building a leading... ...medications. Hybrid: Required to be onsite in Stoughton... ...Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA to support development...SuggestedWork at officeLocal area- ...staffing firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to ensure compliance with FDA and other regulations for medical... ...in regulatory affairs, including experience with 510(k) submissions and interaction with FDA. The candidate should possess a...SuggestedPermanent employment
- Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails preparing and maintaining regulatory submissions, collaborating with cross-functional teams, and providing training on regulatory requirements...Suggested
- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development...Remote job
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...$224.9k - $404.6k
...Norwood MA site and will be responsible for managing a team of CMC experts that prepare and... ...related agency correspondence and regulatory applications. This position will be... ...effective CMC regulatory strategies for submissions(e.g. IND/CTA/BLA/MAA) and identify regulatory...Permanent employmentFull timeWork at officeWork from home- ...and Legal with external partners. Requirements include a finance/accounting background and 3+ years in benefits. The role emphasizes strong communication, data reconciliation, and cross‑functional collaboration in a hybrid work setting. #J-18808-Ljbffr Eversource Energy
- Regulatory Affairs Program Manager (Medical Device Divestiture) Location: Raynham, MA / West Chester, PA / Palm Beach Gardens, FL (Hybrid 3-4 days onsite) Duration: 12+ Months (Extension Possible)... ...global regulatory registrations, submissions, and documentation from a...
$176.92k - $196.58k
...Position:This position is accountable for managing Transmission System Planning’s... ...Planning’s compliance activities and regulatory filings as required by national, regional... ...’s License preferred.#LI-ES3#LI-Hybrid#engajdCompetencies:Build trusting relationshipsManage and...Full timeH1bLocal area$26.92 - $37.74 per hour
...supporting health system operating margin. Management of specialty patients and their drugs is... ...Solutions Schedule: Full Time, Hybrid ESSENTIAL RESPONSIBILITIES / DUTIES... ...served is a plus. Experience with submission of prior authorization requests to third...Full timeFixed term contractInternshipWork at officeRelocation packageFlexible hours$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for... ...The candidate will need to successfully manage multiple projects in a fast and results... ...CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risksProvide...Permanent employmentFull timeWork at officeWork from home- Regulatory Affairs Manager / Regulatory Affairs Specialist role Established in 1991, Collabera has been a leader in IT staffing for over 22 years... ...this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting...Permanent employmentLocal area
- ...Regulatory Affairs ManagerWe are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Synthes, Oberdorf; Zuchwil... ..., pre-marketing, and related submissions to support optimal timelines...Local area
$115k - $120k
...leadership and ensures compliance and operational excellence in managing sponsored funds. The ideal candidate will possess a relevant... ...offers a salary range of $115,000 - $120,000 and the possibility of hybrid/remote work according to university policy. #J-18808-Ljbffr...Work at officeRemote work$184k - $230k
...dispute resolution, CMS submission, and recordkeeping —... ...the Medical, Legal, and Regulatory review committee;... ...organizational, and project-management skills; able to manage... ..., Quality, Medical Affairs, Commercial, Finance,... ...Travel Office-based with hybrid flexibility. Periodic...Contract workTemporary workFor contractorsFixed term contractWork at officeFlexible hours3 days per week$194.55k - $216.17k
...Position: Lead the Company’s distribution regulatory strategies to ensure full recovery and... ...and other retail rate recovery mechanisms.HYBRID WORK POLICYEversource supports work-life... ...and strategic regulatory filings.Manages the regulatory process including assigning...Full timeH1bWork at officeRemote work$100k - $130k
...Business is looking for a Trade Compliance Manager to join our team! As the Trade... ...Manager (Global TCM) for Aerospace. This is a hybrid role (4 days onsite) and can be based in... ...Compliance Program).Analyze and interpret regulatory requirements as they relate to:U.S....Work experience placementWork at officeRemote workMonday to ThursdayFlexible hours$103.11k - $154.67k
....Job SummaryThe Lead Compliance Program Manager will be responsible for development, implementation... ...with established, revised, or new regulatory requirements that impact the... ...and documentation collection, review, and submission. Perform review of regulatory audits results...Full timeWork at officeWork from homeFlexible hours$223.2k - $260.8k
...have over 10 years of experience in pharmaceutical marketing and strong leadership skills. Competitive pay between $223,200 and $260,800 per year, along with bonus eligibility, is offered for this full-time hybrid position. #J-18808-Ljbffr Mallinckrodt PharmaceuticalsFull time$100k - $165k
...our Water Team as a Technical Manager. In this role, you will... ...efforts.Offering Flexible Remote/Hybrid Work Schedule: Expectation is... ...Interfacing with state and local regulatory agencies and permitting... ...replying “STOP.”Unsolicited agency submissions without a signed agreement...Hourly payFull timeContract workFor contractorsFor subcontractorWork at officeLocal areaRemote workFlexible hours$142.5k - $256.5k
...Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC... ...strategies, collaborate with stakeholders, and manage multiple projects to support the... ...effective CMC regulatory strategies for global submissions (IND, CTA, BLA, MAA) and identify regulatory...- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy for Orthopaedics products across multiple... ...in the U.S. You will guide licensing, registrations, and submissions, interfacing with FDA and international agencies to...
- Temp to Perm - Remote Opportunity - Regulatory Affairs Manager Established in 1991, Collabera has been a leader in IT staffing for over 22 years... ...this role, you will lead the preparation, analysis, and submission of dossiers to various governing agencies in supporting business...Remote jobPermanent employmentTemporary workLocal area
- ...Location: Hartford CT, Manchester, NH, Westwood, MA or Berlin CT (Hybrid) The Manager of Distribution System and DER Planning in Connecticut... .... The role requires active leadership in ongoing regulatory proceedings – to drive changes necessary for successful implementation...Full timeContract workLocal area
- Kelly Science and Clinical FSP is seeking a Regulatory Specialist for a long-term engagement with a Global MedTech client. The role is full-time with benefits and is part of our FSP division, a managed solution within Kelly Services, Inc. Responsibilities include providing...Full time
- A leading consulting firm seeks an experienced Executive for product management, managing high-impact technology solutions in a hybrid work environment. The ideal candidate will have over 10 years of experience in InsurTech or FinTech, strong communication skills, and the...
- ...Pharmaceuticals, Inc. is seeking a Supplier Quality professional to lead and maintain the Supplier Management Program, working closely with QA, regulatory, and cross-functional teams in a hybrid Bridgewater, NJ setting. The role emphasizes risk-based decision making, CAPA, audits,...
- State Street is seeking an Officer to manage the client AML KYC periodic review process, working with senior and peer managers to ensure regulatory requirements are met for all reviews assigned. This hybrid role allows balance of work from home and office to match needs...Work at officeWork from home
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