Manager, Regulatory Affairs Rx - [Remote Work Option Available]

Regulatory Affairs/Clinical Affairs Minneapolis, Minnesota Martin, Michigan


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality, affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

PLEASE NOTE:  This role is intended to sit in either Minneapolis, Minnesota or Martin, Michigan (near Grand Rapids, MI), however a remote working situation may also be considered.

The Manager of Rx Regulatory Affairs is responsible for supervising and leading Regulatory Affairs activities for complex-generic products jointly developed with external partnered companies, contract manufacturers, external consultants, CROs, Perrigo product development departments and business interactions with the Food and Drug Administration.

Other key responsibilities include, but are not limited to:

  • Be responsible for independently setting regulatory strategy for complex generic product development programs to comply with FDA regulations and guidance documents and executing the preparation and review of regulatory submissions to US FDA, responses to review questions, FDA meeting requests and briefing packages, controlled correspondence and post-approval supplements.
  • Assess impact of new FDA-related regulations and guidance documents. Work with key internal stakeholders (e.g., R&D, Quality) to implement requirements. They will keep current with all relevant guidance documents and regulations while also monitoring any changes that occur which may impact Perrigo products as well as assess and communicate all FDA requirements to stakeholders in order to maintain compliance without delay to business due to Regulatory issues. The leader in this role will also work with Project Managers to adjust regulatory submission timelines to support the business.
  • Present monthly and quarterly project updates to Executive Steering Committees for Strategic Partnership projects.
  • Support BD due-diligence evaluation of new business opportunities, participate in site visits to assess regulatory impact of potential partners and provide meaningful contributions to the new candidate selection process.
  • Coach and develop junior staff members to become proficient in regulatory decision making.

Knowledge, Experience and Education Requirements:
  • A minimum of 8 years of experience in the pharmaceutical industry and 6 years of hands on experience in Regulatory Affairs which includes prior experience in a leadership role.
  • Bachelor degree in a health care related science (e.g. biochemistry, chemistry, pharmacy, pharmacology) required.  Masters or Ph.D. preferred.
  • Working knowledge of regulatory requirements (e.g. FDA/ICH, GCP, GMP regulations, GDUFA) and first-hand experience with US regulatory submissions for ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA review responses, post-approval supplements and pre-ANDA meeting packages.
  • Prior experience preparing FDA controlled correspondence, briefing packages and conducting meetings with the Agency.
  • Proven ability to write effective responses to FDA application review questions that minimize the number of review cycles.
  • Knowledgeable in regulatory science and ANDA data requirements of all phases of product development for complex-generic products.
  • Highly competent to perform critical reviews of NDA SBAs, clinical protocols and summaries, and due-diligence reviews of regulatory applications for potential product acquisitions.
  • Demonstrate decisive leadership, drive the process, motivate and engage the team’s best efforts, earn respect, and achieve results in an adaptive business atmosphere.
  • Must be entrepreneurial and resourceful and be able to work through complex, enterprise level issues with a systematic approach.
  • Excellent interpersonal communication skills and well-developed collaborative management skills that are effective in working one-on-one with Strategic Partner BD, R&D and RA executives across diverse cultures.
  • Excellent writing skills in both technical and business writing.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.