Boehringer Ingelheim Senior Specialist, Pharma Regulatory Affairs in DULUTH, Georgia
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Support the department in post-approval compliance areas and pre-approval submissions, with the purpose of achieving/maintaining pharmaceutical product registrations and compliance to US State and Federal regulations.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities:
In support of the company's strategic objectives and in alignment with Business Operations, Industrial Operations, CMC and R&D, Quality Assurance and other departments as appropriate, defend and maintain the company's pharmaceutical products.
Ensure compliance for pharmaceutical products throughout the lifecycle in close collaboration with internal departments.
Maintain advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Provides guidance/direction/assessment within the regulatory department and within interdepartmental working groups to address company needs.
Act as liaison with US federal and state government agencies, under the supervision of Pharmaceutical Regulatory Affairs Managers. Assist Managers with the preparation and submission of regulatory submissions for RA Operations activities such as labeling supplements, DERs, EPA monthly and aggregate reports, state licensing renewals, state product renewals, drug product listing, establishment registration, and advertising and promotional materials.
Together with colleagues, support and maintain relevant regulatory databases (Corporate Product Database, archive systems, WWPPS). Assist in development and review of department procedures. Support management for internal audits, agency inspections, etc.
Bachelor of Science degree in life science/engineering, or equivalent, with at least 6 years’ experience in the pharmaceutical industry, ideally part of which is in Regulatory Affairs or a closely related responsibility.
High level of computer skills, including proficiency in Microsoft Word, Excel, Adobe Acrobat, PowerPoint
Advanced knowledge of relevant FDA regulations and guidance
Requires minimal supervision
Excellent verbal and written communication skills; good interpersonal skills
Organized and possesses attention to detail.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Title: Senior Specialist, Pharma Regulatory Affairs
Requisition ID: 1815065