Regulatory Affairs Project Manager

Pro Farm Group
US - California - Davis
July 1, 2024
Management

Job DetailsLevel
Experienced

Job Location
MAIN OFFICE - DAVIS, CA

Salary Range
$92,700.00 - $105,000.00 Salary/year

DescriptionSUMMARY:

ProFarm Group (PFG) is a subsidiary of Bioceres Crop Solutions, a global provider of biologically derived fertilizers, inoculants, crop traits, adjuvants, biostimulants and pesticides, serving the ever-expanding agricultural markets. PFG focuses on discovering, developing, and marketing nature-derived biostimulants, as well as pest management products from microbes and plant extracts for the effective control of invertebrate pests, weeds, and plant diseases.

We are currently looking for a Project Manager of Regulatory Affairs to join our Regulatory group to work with the Director of Regulatory Affairs and other regulatory department team members to register and manage ProFarm Group (PFG) product portfolio in the North America region. Exact scope of responsibility will depend on the chosen candidate's job skills and experience, which will dictate which products and/or countries are assigned to the Project Manager of Regulatory Affairs.

RESPONSIBILITIES AND DUTIES:

Lead the regulatory process and submission of PFG products in the North America region and/or others as needed.
Lead the preparation and submission of 3rd party certifying agencies and compliance authorities
Liaise with regulatory agencies, industry groups, and other stakeholders.
Manage all dossier building activities for PFG products in country, state, etc. as applicable.
Coordinate and manage movement, transport, and release requirements for MBI products falling under Plant Protection Act regulations or similar.
Coordinate and manage regulatory approvals for international experimental use permits and associated import permit requirements for product development or registration purposes.
Assemble and coordinate state regulatory dossiers for biopesticides, biofertilizers, biostimulants and/or other plant health products.
Coordinate outreach to commodity and other user groups to support registrations for PFG products to comply with federal, state, and/or county regulations. Including, but not limited to, attendance and representation at public functions.
Coordinate with Product Development and commercial team to ensure adequate field trials and product labels are completed to support efficacy requirements and supporting marketing materials in key states and countries.
Coordinate and manage projects with R&D teams to develop, expand, and/or resolve queries from regulatory agencies or certifiers. Intra-departmental communication is heavily required.
Coordinate projects with outside consultants as assigned.
Support and help the team with regulatory strategy in regions as assigned timelines and requirements for development tasks needed for submissions.
Other duties as assigned.

QualificationsMINIMUM QUALIFICATIONS:

BS, MS, or PhD in a science-related field, preferably an agricultural discipline, with a minimum of three years' experience in registration/regulatory affairs
Experience with regulatory agencies and knowledge of regulatory procedures, particularly USEPA
Previous experience with biopesticide registration a plus
Previous experience with USDA APHIS PPQ permitting a plus
Microbiology background a plus
Previous experience with aquatic pesticides and US Clean Water Act a plus
Good project management/organizational skills
Excellent communication skills, both written and oral
Fluency in Spanish and/or Portuguese a plus
Ability to meet deadlines and work well under pressure
Strong attention to details
Professional demeanor
Computer literate
Some knowledge of GLP/GMP/QA compliance requirements is a plus

The individual should appreciate our entrepreneurial, fast-paced, agile, and dynamic work setting. He/she should be enthusiastic and energetic, goal-driven, and highly motivated to complete tasks in a timely, efficient manner. The candidate should also thrive in a strong team environment, be a self-starter and comfortable speaking up in company meetings. An individual who is positive, interactive, resourceful and creative in problem solving by thinking "out of the box" will be highly valued in this role.

ESSENTIAL PHYSICAL AND MENTAL REQUIRMENTS:Physical Requirements:

Ability to sit at a desk for extended periods
Ability to extensively use a computer keyboard, mouse, monitor and software

Mental Requirements:

Ability to work with frequent interruptions, changes in workload priorities, and maintain confidentiality
Ability to handle and plan multiple projects and tasks simultaneously under stringent deadlines
Ability to learn new software/new information, when necessary, to complete job duties thoroughly.
Ability to utilize excellent people skills and work in a team environment.
Ability to have a high level of proficiency of the English language, both in verbal and written form.
Ability to have strong attention to detail and accuracy is essential in this position

BENEFITS:

401(k) plan with employer match
Medical, dental, & vision coverage
Life insurance coverage
Long term disability
Flexible spending account for dependent care and/or medical expenses
Employee Assistance Program
Vacation accrual starting on first paycheck
13 fully paid holidays

Compensation for roles at PFG varies depending on a wide array of non-discriminatory factors including but not limited to the specific office location, role, degree/credentials, relevant skill set, and level of relevant experience. At PFG, compensation decisions are dependent on the facts and circumstances of each case. Total rewards at PFG include salary + bonus (if applicable) + benefits. Your recruiter may be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the hiring process.

The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive and other duties may be assigned. This job description may be modified as needed.

PFG is an equal-opportunity employer. A pre-employment background check will be required.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

Read the full job description and apply online on the recuiter's web-site

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