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23 days old

Manager, CMC Regulatory Submissions III

Kelly Services
Lexington, MA 02421
JOB TITLE: **Regulatory Affairs Manager**



Position Type: Temporary



**Job Description** :



Under the direction of the CMC Submissions line manager, the CMC Submissions Lead is responsible for execution of global CMC Regulatory Submissions operational activities in support of pipeline programs IMPD/CTA/IND , Marketing Applications NDA, MAA, BLA, JNDA and Agency request for information, Post- Approval changes, etc..The lead will be tasked with establishing global submission activities and timelines in partnership with global and cross functional stakeholders in PD TS, Plasma and Biologics Operating Units, Regulatory Affairs and QA and will execute operational activities pertaining to the CMC submissions portfolio ensuring critical issues are addressed and milestones are being met. Adherence to established business processes and standard tool usage is expected.Regulatory Submissions Management Planning and tracking for CMC submission activities for the assigned product/project, ensuring appropriate stakeholder engagement and participation. Support operational excellence for CMC regulatory submissions by adhering to and applying established processes and tools. Day-to-day management of CMC regulatory submissions, including preparation for and leading of meetings, document manipulation and routing for authoring and review, etc. Provide guidance for submission eCTD granularity and global CMC submission requirements. Enable high quality CMC documents through content review and compliance to submission ready standards Develop and maintains strong communication and collaboration with the stakeholders.



**Requirements:**




+ Be proficient on the EDMS system and provides support to end users to ensure effective utilization of document management systems.

+ Bachelors degree or advanced degree in Chemistry, Pharmacy, or closely related field is highly desirable.

+ Minimum 5 years experience in the Pharmaceutical Industry or relevant Regulatory environment including experience in CMC and regulatory submission management.

+ Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions in particular CMC Module 3 information and QOS documents throughout the development lifecycle desired.

+ Solid working knowledge of current GMP and ICH guidelines and regulatory requirements. Knowledge of drug development for drug substance and drug product. Project Management skills.

+ Ability to take the initiative, work independently, and complete tasks to deadlines Requires very strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.

+ Requires excellent interpersonal, diplomatic communication, analytical, and organizational skills.

+ Ability to effectively present information to management and employees at various levels of the organization.

+ Appropriately escalates issues for swift resolution with recommendation Knowledge of Submission Ready standards application desirable.

+ Experience with documentum and publishing tools is desirable.

+ Strong knowledge of Windows environment and Windows-based desktop productivity applications including Word, Excel, Adobe Acrobat and MS Project.

+ Electronic Document Management as well as advanced Microsoft Word capabilities is preferred.

+ Critical competencies: building authentic relationships, global and cross boundary communication and partnership.

+ Strong team player.

+ Requires problem solving ability, multitasking and the skill to present complex issues in oral and written form.

+ Understanding of objectives and processes across multi-disciplinary functions involved in drug development, registration compliance and quality GxPs .

+ Ability to participate in occasional early or late meetings/teleconferences. Working hours flexibility to meet submission deadlines.






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-25 Expires: 2019-11-25

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Manager, CMC Regulatory Submissions III

Kelly Services
Lexington, MA 02421

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