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Regulatory Manager - 11791

Simply Biotech San Diego ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Regulatory Manager – Simply Biotech

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for Regulatory Manager at our client, an “essential business”, located in San Diego, CA who possess:

  • Bachelor’s degree in Biochemistry, Biology, or related field
  • 5+ years of industry experience as a Regulatory Manager
  • Must have some microbiology background
  • Previous supervisory experience is a plus

Email your resumes to akubota@simplybiotech.com or call 858.239.2851

FULL DESCRIPTION: The Regulatory Manager will support the company’s efforts to obtain new product registrations, permits and approvals in domestic and international markets. The Regulatory Manager will be responsible for compiling, submitting, and supporting regulatory dossiers for livestock and pet products in the US and worldwide.

The selected candidate will further possess:

  • Strong analytical thinking, problem solving skills, and attention to detail
  • A deadline driven individual with a sense of urgency and an ability to meet deadlines
  • Understanding of the US GRAS self-affirmation process
  • Strong technical skills and working aptitude in microbiology and/or biology (microbiology experience preferred)
  • Possess a desire to make a meaningful difference and think outside the box
  • Must be self-motivated with the ability to travel and work independently
  • Proficient computer skills including Microsoft office suite required; statistical software a plus (e.g. JMP)
  • Holds a competes to win attitude while willing to collaborate effectively across cross functional teams to grow the business with an ownership mentality
  • Excellent interpersonal and communication skills
  • Strong relationship building skills and ability to pivot/focus on regulatory opportunities and challenges as they arise

The selected candidate will be responsible for:

  • Plan, conduct, and supervise assignments with little to no direction
  • Review team progress and evaluate results
  • GAP analysis of existing dossiers
  • Long-term planning and execution of experiments required for regulatory approvals well in advance of submission
  • Plan and assign personnel for given projects or tasks
  • Assist with the review and evaluation of personnel performance
  • Monitor and assess performance of self, other individuals, or the organization to make improvements or take corrective action
  • Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, and/or approaches to problems
  • Recommend changes in procedures
  • Build internal and external relationships and supports culture through daily interactions
  • employees to meet all regulatory requirements.
  • May perform other duties as assigned including accepting primary accountability for special projects as needed.
  • Perform other duties as assigned
  • Current knowledge of regulations in agriculture markets worldwide to identify additional countries to expand into as well as guide the company's compliance strategies worldwide
  • Compiling, submitting, and supporting regulatory dossiers for livestock and pet products in the US and worldwide
  • Developing and maintaining an organized system of regulatory related data, communications, and documentation relayed to company counsel for completion of regulatory filings
  • Demonstrated ability to build a process that can adapt to dynamic business needs, while maintaining compliance
  • Work with global regulatory consultants to identify requirements, provide necessary information, documents, and certification for approval in respective countries
  • Be a regulatory advisor to research and development for use of approved ingredients, certifications needed for shipment and registration of products through individual states
  • Work with OUS and US legal counsel on establishment and maintenance of trademarks, patents and certifications
  • Work with regulatory consultant providing regulatory documentation for submissions for meetings, regulatory filing, and certifications for marketing of products in the US
  • Work with ad agency, legal and state registrations to develop an approved label for products in US and OUS

For immediate and confidential consideration, please email your resume to akubota@simplybiotech.com or call 858.239.2851

More information can be found at www.SimplyBiotech.com

Company Description
Recruiting is a lost art. We’ve brought it back to the basics. Here’s how.

Helping People Succeed.
As a part of the TalentZök family, we focus on helping you identify the best talent. Whether you’re seeking temporary help or help on a direct hire basis, Simply Biotech and the TalentZök family of companies can connect you to the right person for the job.

Biotech. It’s all we do.
We believe that effective and successful recruiting must be specialized. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. At Simply Biotech, we focus only on the biotech/device industry.

No “resume farming” here
The most talented people rarely post their resumes to job boards. They are out there working, untapped. Many don't even know they are interested in better opportunities because they are passive job seekers. You want the best person for the job and chances are, the best person doesn't have their resume posted. They may even be working for your competitor. So searching the job boards along with every other biotech firm won't get you the result you're looking for. Only old-fashioned recruiting - picking up the phone, networking and finding the talent in the workforce - will get you the perfect match.

Thank you for calling
We've picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? At Simply Biotech, customer service is our priority. We return calls promptly. We don't let you fall through the cracks. It sounds so simple yet so few know how to do it right.

We do our homework - to save you time
Before filling a position, we speak with many of the people involved in making the decisions and ask quite a few questions. While this takes a little longer in the beginning of the process, it allows us to better understand what’s most important in a candidate. That way, we send only qualified candidates who will be in line with what you’re looking for.

Many recruiters just forward resumes to clients. At Simply Biotech, we conduct a thorough interview with each candidate before presenting them to you. We speak with them about their experience at each position and find out who they reported to, what their responsibilities were, and why they left. Many times this uncovers information that is omitted in the resume and that may be vital to your decision. We feel that it is our responsibility to thoroughly screen candidates before presenting them to you. This process results in fewer, better candidates for you to consider - and saves you time.

Simply Biotech

Recruiting is a lost art. We’ve brought it back to the basics. Here’s how. Helping People Succeed. As a part of the TalentZök family, we focus on helping you identify the best talent. Whether you’re seeking temporary help or help on a direct hire basis, Simply Biotech and the TalentZök family of companies can connect you to the right person for the job. Biotech. It’s all we do. We believe that effective and successful recruiting must be specialized. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. At Simply Biotech, we focus only on the biotech/device industry. No “resume farming” here The most talented people rarely post their resumes to job boards. They are out there working, untapped. Many don't even know they are interested in better opportunities because they are passive job seekers. You want the best person for the job and chances are, the best person doesn't have their resume posted. They may even be working for your competitor. So searching the job boards along with every other biotech firm won't get you the result you're looking for. Only old-fashioned recruiting - picking up the phone, networking and finding the talent in the workforce - will get you the perfect match. Thank you for calling We've picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? At Simply Biotech, customer service is our priority. We return calls promptly. We don't let you fall through the cracks. It sounds so simple yet so few know how to do it right. We do our homework - to save you time Before filling a position, we speak with many of the people involved in making the decisions and ask quite a few questions. While this takes a little longer in the beginning of the process, it allows us to better understand what’s most important in a candidate. That way, we send only qualified candidates who will be in line with what you’re looking for. Many recruiters just forward resumes to clients. At Simply Biotech, we conduct a thorough interview with each candidate before presenting them to you. We speak with them about their experience at each position and find out who they reported to, what their responsibilities were, and why they left. Many times this uncovers information that is omitted in the resume and that may be vital to your decision. We feel that it is our responsibility to thoroughly screen candidates before presenting them to you. This process results in fewer, better candidates for you to consider - and saves you time.

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San Diego, CA
USA

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