What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Title: Regulatory Affairs Specialist
Company: US Tech Solutions
Client: Celgene
Job type : Contract
Duration: 12 months
Location: south planinfield NJ
ID: 5175
Job description:
- Regulatory-CMC consultant - Biologics
- DEPARTMENT Regulatory Affairs
- PREREQUISITES
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with
- a minimum of 7 years in the pharmaceutical industry, and a minimum of 5 years CMC regulatory (biologics preferred) experience.
Responsibilities will include, but are not limited to, the following:
- Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings.
- Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.
- Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.
- Responsible for the management of CMC activities related to specific developmental or commercial compounds.
- Responsible for the regulatory evaluation of CMC change controls.
- Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.
- Take a leadership role in the CMC development/commercial teams.
- Maintain knowledge of global regulatory environment, regulations and procedures.
Skills/Knowledge Required:
- Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
- Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.
- Thorough knowledge of FDA, EMEA and ICH guidelines.
- Knowledge of rest of world pre- and post-approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in the biologic drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams
- prior supervisor or project management experience
- Experience with global CMC regulations for biological compounds.
Additional Information
All your information will be kept confidential according to EEO guidelines.
