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POSITION SUMMARY:
The Regulatory Affairs CMC Specialist 2-Contractor will contribute to CMC teams in support of commercialized products (post approval) and throughout the development programs of Halozyme partner’s therapeutic candidate projects. The CMC Specialist will be responsible for the coordination of authoring CTD sections, documents and reports to be submitted to Regulatory Authorities. Working with the CMC functional groups and Regulatory CMC management, the CMC Specialist will be accountable for delivering quality submission packages on a timely basis to achieve development goals and support the ongoing commercialization of Halozyme’s enzyme products.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Implement Regulatory CMC activities to achieve product development goals and support the ongoing commercialization of Halozyme’s enzyme products
Execute developed regulatory CMC strategies effectively
Identify and implement tactics, key messages and positioning to achieve the earliest possible approvals of all regulatory CMC submissions
Coordinate authoring, development and internal approvals of Regulatory CMC documents and applications
Support the management of regulatory CMC activities for key projects and coordinate filing efforts between corporate disciplines
Define and document risks and key regulatory CMC issues related to the pre-clinical and clinical development and manufacturing of products
Assure compliance with U.S. and international regulations by advising CMC groups and providing references to published regulations, guidance and precedence
Represent the RA CMC group as a regulatory CMC specialist in responding to corporate alliance team questions to facilitate the attainment of the corporate alliance objectives
Provide information and background information for the interaction and negotiation with domestic and foreign regulatory agencies
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline with at least some experience in a biopharmaceutical company involved with clinical development, manufacturing, or testing of ethical biopharmaceutical products (an equivalent combination of education and experience may be considered)
RAC certification or equivalent
Hands-on experience assembling content used in U.S. and international submissions, a working knowledge of FDA/EMA regulations, the regulators, and the drug approval process
Demonstrated experience in applying regulatory CMC knowledge to various situations and serve as a source of competitive advantage to the Company.
Proven experience in all components of regulatory submissions including Chemistry, Manufacturing and Control, non-clinical, and clinical documentation
A higher degree (Masters, PhD) is preferred, but not essential
Additional experience in a smaller, biotech company is a plus
Exposure to filing U.S. submissions for biologics and drugs (e.g. INDs, NDAs, BLAs, Annual Reports, Amendments, Supplements, DMFs). Submission experience in oncology, dermatology, and matrix targeted therapeutics desired
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: N/A
INTERNAL AND EXTERNAL RELATIONSHIPS:
Work cross functionally with clinical, pre-clinical, quality, manufacturing, marketing, commercial, and product management
Interface with external vendors and partnerships
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 10% of your time
