Apply on Employer Site

Boehringer Ingelheim · 7 hours ago

Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy

Duluth, GA

Full-time

Onsite

Lead/Staff, Director/Executive

2+ years exp

Boehringer Ingelheim is a global company focused on improving lives through innovative healthcare solutions. The Manager and Associate Director of Regulatory Affairs will represent the US regulatory safety and efficacy function in global development projects, ensuring compliance with regulations and leading the strategy for product approvals.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable

Responsible for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects

Works in project teams as an RA sub team member in accordance with the project governance model to drive Target Product Profile objectives

Provides consistent regulatory advice to project teams regarding the pathways and approaches to regulatory approvals with details pertaining to time to market, costs, and robustness/marketability of each approval

Represents company at external functions, such as trade association meetings, to support BI interests

Participates in due diligence processes by providing input into the regulatory assessment

Participates in the evaluation of the product dossiers for regulatory compliance and suitability for registration

Represents RA for infrastructural processes and projects

Responsible for the successful update of regulatory tools as defined

Supports specific infrastructural projects as assigned

Responsibility for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable

Responsibility for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects

Work in project teams in accordance with the project governance model to drive Research Profile/Target Product Profile and Quality Target Profile

Provide consistent regulatory advice to project teams regarding the pathways and approaches to regulatory approvals with details pertaining to time to market, costs, and robustness/marketability of each approval

Serve as RA core team member for project teams

The role of a RA core team member includes steering all regulatory aspects of development and includes leading of subteams

Serve as Subject Matter Expert on the current US regulatory environment and potential trends. Recommend and communicate proactive approaches to regulatory issues

Facilitate partnerships, both formal and informal, with key regulatory agency review staff

Participate in due diligence processes by providing regulatory assessment and expertise

Responsibility to evaluate product dossiers for regulatory compliance and suitability for registration

Pro-active representation of RA for infrastructural processes and projects

Responsible for the successful update of regulatory tools as defined

Lead/support specific infrastructural projects as assigned

Active representation of company at external functions in order to drive agenda with BI best interests in mind

Communication interface and influencer with the veterinary regulatory authorities and industry associations

Responsible for proactively seeking contact with regulatory authorities directly, as appropriate, and positioning BI as a trusted and innovative partner (key account management)

Ensure a balanced relationship with the authorities

Qualification

Regulatory Affairs experienceFDA submissionsVeterinary product knowledgeAdvanced degreeRegulatory strategy developmentRegulationsOrganizational capabilitiesEffective communicationTeam collaborationNegotiation skillsSelf-motivation

Required

Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry OR Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry

Excellent command of English language, both written and spoken

Regulatory Affairs or equivalent pharma industry experience is required

Intrapreneurial spirit while being rigorous and disciplined with compliance requirements

Ability to collaborate in a global organization and manage a full workload across multiple projects

Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships

Able to meet stringent time and quality demands

Strong team player who is collaborative with the mission of BI, but able to drive change

Ability to handle high workloads and understanding of cultural differences

Well-developed organizational capabilities

Self-motivated

Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) from an accredited institution with a minimum of five (5) years related experience in Regulatory Affairs strategy/execution OR Masters from an accredited institution in relevant scientific discipline with minimum ten (10) years experience in Regulatory Affairs strategy/execution

At least five (5) years in Regulatory Affairs positions, or equivalent in the pharmaceutical industry

Must include a minimum of two to three (2 to 3) years conveying exposure to authorities (e.g. in new product development or complex maintenance projects, leadership of RA subteams)

Sound knowledge of the legal requirements for approval of veterinary medicinal products

Awareness of the industry/direct competitor's activities

Knowledge in relevant Regulatory Affairs areas

Ability to understand and anticipate regulatory trends

Knowledge and established understanding of regulatory legislation and requirements for the development and maintenance of veterinary products with a focus on safety and efficacy aspects

Regulatory Affairs or equivalent pharma experience in animal health is required including prior FDA/CVM/EPA interaction

Demonstrated ability to successfully collaborate in a global organization and manage a full workload across multiple projects

Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes

Self-motivated with a high degree of initiative, commitment and persistence

Well developed organizational capabilities

Strong team player who is collaborative with the mission of BI, but able to drive change

Ability to handle high workloads and understanding of cultural differences

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Preferred

Knowledge in international product registration and/or product development is desired

Benefits

Competitive compensation and benefit programs

Health and wellbeing programs

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees