Reference Number: JO-2005-449907
RA CMC Manager
Job Type: Permanent
Location: Dublin City Centre
Role: RA CMC Manager
Location: Dublin, Ireland
Salary: competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. In this role you will independently prepare regulatory assessments and author CMC regulatory documentation and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle
Other duties will include:
Contribute as the CMC representative on core projects and advise on CMC regulatory strate-gies for programs in accordance with regulatory, scientific & technical criteria.
Assist in developing and implementing strategies for the earliest possible approvals of regula-tory submissions.
Ability to identify and present issues for resolution, communicate regularly with key stakehold-ers to ensure alignment on CMC regulatory issues.
Maintain CMC related submission information in the relevant systems, track regulatory com-mitments and timelines for specific projects/products/markets.
With minimal supervision, plan, author and manage the assembly and timely submission of CMC related sections of IMPDs, INDs, NDAs, MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements.
Coordinate and contribute to responses to Agency queries.
Ensure regulatory submissions are maintained in compliance with regulatory requirements.
Participate on project teams and provide expertise on CMC regulatory matters.
Prioritise and independently complete assigned workload appropriately.
Develop and maintain current regulatory knowledge and awareness of new scientific or manu-facturing technology and advise management of significant developments.
5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology indus-try; experience with biological products a distinct advantage.
Experience and knowledge in preparation of CMC sections of IMPD, IND, MAA, NDA, and sup-portive amendments and supplements. Experience with CTD/eCTD.
A minimum of 3+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
Working knowledge of EMA, FDA and ICH regulatory guidance and regulations.
Experience of dealing with regulatory agencies is preferred.
Enough level of knowledge and solid understanding of the development and commercial activi-ties and cGMPs required to assess technical, scientific and regulatory merits of CMC infor-mation, commitments and data to advise teams and/or project(s).
An understanding of regulatory requirements and expectations, criteria for submission and approval globally.
Prior experience managing projects is preferred.
Outstanding written and verbal communication skills.
If you would like to apply for this position, please contact Amani via amani.yousef@Regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*