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Manager, Regulatory Affairs -Cmc

Manager, Regulatory Affairs -Cmc
Empresa:

Halozyme


Lugar:

Zacapa

Detalles de la oferta

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We look forward to discovering your talents.

POSITION SUMMARY:
The Manager, Regulatory Affairs (RA) primarily provides support in the development and implementation of global regulatory CMC strategies for Partners’ marketed and development products. This individual leads or supports regulatory activities for internal and external programs and works closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings for external collaboration Partners. As opportunities arise, the Manager may also contribute to clinical discussions and reviews of documents to support clinical investigations by Partners.Working with the entire RA group, the Manager will also contribute to the development, implementation and maintenance of a comprehensive knowledge management capability in the RA group to support Halozyme’s and Partners’ regulatory needs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Coordinate and review regulatory submission documents and development activities to support regulatory filings
Effectively work with internal, external and vendor resources to manage global regulatory activities
Interpret regulations and provide well-reasoned regulatory guidance to cross functional project team
Support or lead the preparation of health authority meeting materials and lead responses to requests for information
Support RA management with development and implementation of working procedures, standard operating procedures and policies
Research, prepare, and present on global regulatory topics to internal and external stakeholders
Assure compliance with all applicable (domestic and international) regulations including regulatory change management
Monitor industry and regulatory trends and be able to apply learnings and provide guidance related to such trends to regulatory and functional teams
Compile and maintain regulatory files and trackers for regulatory information and submission preparation
Evaluate change requests and provide global Regulatory assessment and coordinate associated submissions

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum of a Bachelors’ degree in science with at least 3 years’ experience in Regulatory Affairs CMC in the biotechnology or pharmaceutical industries or 5 years in another function and with demonstrated transferrable skill sets (an equivalent combination of education and experience may be considered)
Demonstrated experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process
Proven experience and success in applying regulatory knowledge to various situations
Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel in other functional groups both internally and outside the company
Experience working in laboratory or manufacturing roles is essential
Excellent writing, communication, and interpretive skills
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently
Biotech product experience and regulatory knowledge is essential
Experience filing and knowledge of European/global submissions is a plus
Experience in regulatory management of commercial products is a plus

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), SharePoint. Knowledge of other software required: N/A

INTERNAL AND EXTERNAL RELATIONSHIPS:
Work cross functionally with research, analytical, clinical, quality, manufacturing, marketing, commercial, and product management. Manage 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 5% of the time


Fuente: Myworkdayjobs

Requisitos

Manager, Regulatory Affairs -Cmc
Empresa:

Halozyme


Lugar:

Zacapa

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