This position is responsible for leading and directing the Regulatory Affairs department. This role is responsible for effectively interpreting guidelines, regulations, and policies, to provide guidance on regulatory expectations and strategies throughout the development of the Bedford product line. This person provides strategic consultation to the Product Development and Business Development function. Interfaces with FDA on ANDA and 505(b)(2)NDA filings and product maintenance. Works closely with Product Development to stream-line documents and filings to be state of the art in the industry so Bedford can use this as a strategic advantage.
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:
Develops regulatory strategies both pre and post approval that comply with regulations while meeting BVL business needs. Drives timelines for Bedford ANDA and 505(b)(2) activities to meet requirements.
Provides PPD and Bedford with submission strategies and advises on developmental work required to support regulatory submissions.
Oversees the planning and execution of bioequivalence studies (clinical and non-clinical trials) with regard to budget and milestone completion.
Oversees and ensures compliance with respect to adverse event reporting, compendial compliance and labeling regulations.
Maintains communication with regulatory agencies in regards to regulatory applications, field alerts, recalls, and inspections to address questions, provide routine updates and promote/develop positive relationships. Negotiates difficult and complex issues with regulatory agencies to provide successful outcomes for BVL. Notifies upper management concerning FDA communications and application status.
Provides leadership and management of direct reports as well as the entire department staff. Coaches and develops employees to create a successful team and succession plan.
Interprets and applies new FDA laws/regulations applicable to BVL and advises PPD, Bedford, Legal, Manufacturing & Quality.
Acts as the primary contact for communications with the FDA.
Provide creative and value added filing strategies to meet the Bedford business model requirements for differentiated products. Performs expert witness duties in support of Paragraph IV filings.
Requirements:
Requires Bachelor of Science degree in Chemistry, Biology, Pharmacy or other related scientific discipline. Advanced degree preferred.
Strong knowledge of pharmaceutical industry operations, plus direct experience with submission of ANDAs and 505(b)(2)applications.
Excellent management and decision making skills, including negotiating capabilities.
Ability to delegate appropriate duties, and provide strategic direction.
Extensive knowledge of FDA and other regulatory agencies regulations and cGMP requirements.
Excellent communication skills, both oral and written.
Good computer skills including proficiency with Microsoft Office products (Word, Excel, Access, Power Point).
Desired Experience, Skills and Abilities:
Minimum 10 years experience in Regulatory Affairs support in the generic industry is required. Previous experience working with Product Development is a plus.
Previous experience working directly with FDA and other health authorities is required.
Requires Bachelor of Science degree in Chemistry, Biology, Pharmacy or other related scientific discipline. Advanced degree preferred.
Strong knowledge of pharmaceutical industry operations, plus experience with submission of independent marketing applications.
Excellent management and decision making skills, including negotiating capabilities.
Previous experience working directly with FDA and other health authorities is required.
Ability to delegate appropriate duties, and provide strategic direction.
Extensive knowledge of FDA and other regulatory agencies regulations and cGMP requirements.
Excellent communication skills, both oral and written.
Good computer skills including proficiency with Microsoft Office products (Word, Excel, Access, Power Point).
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Our Culture:
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. 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. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
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 background investigations and drug screenings.
Job
-
Regulatory/Compliance
Primary Location
-
Americas-United States-Ohio
Other Locations
-
Americas-United States-Ohio-Bedford
Organization
-
Ben Venue Labs
Schedule
-
Full-time
Boehringer Ingelheim - 9 months ago
- save job
-
block
