This position is responsible for Regulatory management (to include preparation, submission, liaison, tracking, and maintenance) of assigned projects/products (to include IND, DMF, NDA/ANDA’s, CTA, NDS and related correspondence); responsible for Regulatory compliance activities (to include change control management and annual report preparation); Regulatory knowledge management; and Regulatory consultation.
Responsible for the management and completion of activities associated with regulatory filings in (CTD and eCTD) to include preparation, submission, liaison, tracking, and maintenance in support of assigned IND’s, DMF’s, NDA/ANDA’s, CTA’s, NDS and related correspondence.
Management of Regulatory compliance activities to include the review and approval of change controls; commitment management, Regulatory Compliance Manuals, annual report preparation, etc.
Review and approval of technical reports written in support of regulatory submissions.
Review of validation documentation including manufacturing process protocols and master batch records.
Review of technical documents and reports (such as review development reports); provide guidance/consultation for the preparation of various sections (with an emphasis on the CMC section), to insure successful regulatory filings in compliance with Regulatory agency requirements.
Provide training to support RA and Product Dev. personnel or other site personnel, as requested.
Provide guidance, support, and participation in project management activities and project teams as a core team member for assigned projects.
Participate in investigations of development and/or production problems and help define solutions.
Interface with Operations and PD management to schedule current projects.
Review and communicate updates regarding Regulatory guidance’s, directives, policies, etc. in support of ongoing project/product activities. Maintain and expand current Regulatory knowledge and experience.
Provide Regulatory and scientific expertise (internally and externally) regarding Regulatory requirements on products/projects.
Assist in the development of business proposals for Regulatory support services.
Perform specific project related work as requested.
Develop specific objectives and manage work assignments in an effort to achieve personal objectives in conformance with overall business goals.
Provide coaching to one or more employees in the preparation of annual report and supplemental submissions for NDA, NDS, IND and DMF.
May lead work of others who perform essentially the same work. May organize, set priorities, schedule and review work, but has no responsibility to hire, terminate, review performance or make pay decisions.
Minimum Job Qualifications
Education: Bachelor’s Degree in Science discipline (Chemistry, Biochemistry, or related pharmaceutical science) required. Advanced degree is preferred.
Experience: Minimum of 6 years pharmaceutical Regulatory Affairs experience supporting both development projects and marketed products is required.
Licenses, Certificates, Registrations
Regulatory Affairs Certification is preferred.
Capability in Electronic Submission Template is preferred.
Direct experience in preparation, submission and life-cycle management of applications in eCTD format, including as primary Regulatory author
Working knowledge of the drug development process,
Working knowledge of regulatory guidelines and regulations (US and international) to include FDA requirements for INDs, ANDAs, NDAs, DMFs
Experience interfacing with US and international regulatory authorities
In depth knowledge of cGXP/ICH guidelines and regulations
Familiarity with Regulatory databases and search techniques.
Ability to work in a dynamic environment with a high degree of flexibility
Proven ability to interact effectively across multiple functional groups and projects
Excellent prioritization and organizational, and problem solving skills
Positive flexible outlook
Solid working knowledge of MS Office (Excel, Word, PowerPoint, Access, Outlook), and experience with the Internet. Familiarity with Regulatory databases and search techniques.
Language Ability - Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from regulatory agencies, or members of the business community. Ability to write regulatory submissions and correspondence that conform to prescribed format and convey the information clearly and logically. Ability to effectively present information to top management, public groups, and/or customers/business partners.
While performing the duties of this Job, the employee is frequently required to talk or hear. The employee is occasionally required to stand; walk; sit; use hands to finger, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and /or move up to 50 pounds. Specific vision abilities required by this job include close vision. The employee works under typical office conditions with the noise level in the work environment being usually quiet to moderate.
Additional Salary Information: Depends on experience
Recro Pharma (NASDAQ: REPH) is a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain. Recro Pharma is currently developing IV/IM Meloxicam, a proprietary, Phase III-ready, rapid-onset, long-acting preferential COX-2 inhibitor, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine in Phase II, b...oth for the treatment of acute post operative pain. As Recro Pharma's product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress while maintaining analgesic effect.
Recro Pharma owns and operates an 97,000 square foot, DEA-licensed facility that manufactures five commercial products that are commercialized by partners and receives royalties associated with the sales of these products.