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Regulatory Affairs Manager - San Diego, CA

Kelly Services

San Diego, CA
Job Code:
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Job Details

Job Title Regulatory Affairs Manager - San Diego, CA

Jobid US15TPCG_BH1430478

Location: San Diego, CA, 92108, USA

Description **Regulatory Affairs Manager**


Reporting directly to the Sr. Director, Regulatory Affairs, the Manager, Regulatory Affairs is responsible for planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.


Primary Responsibilities

+ Prepares and compiles Amendments, Supplements, Annual Reports, 505(b)(2) and 351(k) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
+ Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
+ Participates in the establishment of project plan due dates and ensure that the due dates for milestones are met.
+ Interfaces with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.
+ Assists in promoting sound strategies in support of submission goals.
+ Participates in project team meetings and provides regulatory acumen to staff and internal team members in support of projects.
+ Manage, in line with company's procedures and in collaboration with the project team, the preparation, compilation (including writing as necessary), assembly, review and filling (as appropriate) of regulatory documents in relationship with the drug development process
+ Participates in change control management according to Pfenex's change control procedures
+ Preparation and maintenance of a central source of Regulatory Intelligence information, including but not limited to his/her assigned project and general EU and US regulatory guidance information
+ Ensure all program deliverables are met according to timelines, budget, operational procedures and quality standards
+ Maintenance and archiving of regulatory documentation according to internal Standard Operating Procedures (SOPs)

+ Minimum of 7 years in the pharmaceutical industry with 5 of those years in regulatory affairs.
+ Prior experience in the Generics industry preferred
+ Demonstrated understanding of financial and resource planning systems and processes with the ability to coordinate project-level budget/resource estimates and manage actual vs. plan
+ Advanced level proficiency with MS Project, including building complex schedules with logical relationships between successors and predecessors
+ Exceptional time-management abilities and strong follow-through skills required
+ Understanding of GLP, cGMP, and GxP environments
+ Experience and/or exposure to the full life cycle of a biopharmaceutical parenteral product from development through IND
**_Education_** :

+ Minimum of a Bachelor's Degree in a life science. A Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred.
+ RAC preferred
**_Additional Information_**

+ Affirmative Action and Equal Opportunity Employer (EOE)
+ No agencies or phone calls please
+ Pfenex celebrates the diversity of life and welcomes all individuals to apply
+ Must be legally authorized to work in the US without sponsorship

+ The employee is regularly required to sit, stand, walk; reach with hands and arms, use hands to finger, handle or feel.
+ The employee is required to regularly lift and/or move up to 20 pounds.
+ Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

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

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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