RA Senior Manager CMC

Employer
ProClinical
Location
Baltimore, MD
Posted
Sep 20, 2022
Closes
Sep 24, 2022
Ref
655472390
Industry
Other
Hours
Full Time
Proclinical is seeking to hire a RA Senior Manager CMC located in Baltimore, MD.Job Responsibilities:You drive the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements.You provide regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply. Ensures adequate interaction and partnership with the Global Regulatory Lead's team in order to define proper regulatory CMC filing strategy.You lead CMC Regulatory discussions during interactions with Worldwide regulatory authorities.You ensure, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.You engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment). He/She, in a continuous improvement mindset, will ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams.You mentor or train staff. May have direct line or lead management responsibility.You may participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.You deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).Skills and Requirements:Degree in Sciences or Medical SciencesDetailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.Proven project management and multi-tasking skills.High ability to manage and direct multiple projects/teamsTrack record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settingsDemonstrated ability to handle complex global CMC issues through continuous change and improvement.Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.Regulatory Affairs Certification (eg RAPS)Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadershipContinued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.Identified as CMC Regulatory expert in a specific subject area.Highly developed interpersonal, presentation and communication skills.Proven experience in supervising and training staff within an organizationIf you are having difficulty in applying or if you have any questions, please contact Ishmam Quddus at (+1) 718-577-5021 or i.quddus@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#LI-IQ1Job Requirements:*Degree in Sciences or Medical Sciences *Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise. *Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. *Proven project management and multi-tasking skills. *High ability to manage and direct multiple projects/teams *Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings *Demonstrated ability to handle complex global CMC issues through continuous change and improvement. *Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree. *Regulatory Affairs Certification (eg RAPS) *Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership *Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements. *Identified as CMC Regulatory expert in a specific subject area. *Highly developed interpersonal, presentation and communication skills. *Proven experience in supervising and training staff within an organization

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