Senior Director, Regulatory Affairs

Regulatory Affairs South Plainfield, New Jersey


Description

Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D.

Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.

Cosette is headquartered in Bridgewater, NJ with 2 additional locations in the U.S. The South Plainfield, NJ office consists of an R&D Laboratory and other functional areas. The Lincolnton, NC site is a fully functioning, state of the art, manufacturing facility.

Innovating every day.™

Reporting directly to the CEO the ideal candidate will be responsible for representing Cosette Pharmaceuticals on all regulatory issues involving FDA regulatory agencies. Lead a team of regulatory professionals. Drive Regulatory strategy of Cosette, advise employees on regulatory requirements for all dosage forms and delivery systems, and recommend appropriate actions.

Essential Functions and Responsibilities

  • Represent Cosette Pharmaceuticals and lead and communicate on all regulatory issues involving the FDA and other regulatory health authorities for all products and businesses.
  • Manage a team of regulatory professionals.
  • Expertise in original ANDA/Post Approval Supplement and eCTD submissions.
  • Responsible for planning and managing the preparation, submission and maintenance of all regulatory submissions, both NDA and ANDA, on behalf of the Company.
  • Manage all Annual Reports and PADERs for registered products.
  • Responsible for product labeling and artwork management.
  • Perform regulatory risk assessment and provide regulatory input to the CEO and executive team.
  • Become part of strategy and development team by providing regulatory strategy for new development, as well as approved products.
  • Responsible for the review and approval of Standard Operating Procedures (SOP) relating to preparation, submission and reporting information to regulatory authorities. Prepare, plan and implement new processes and policies to improve efficiency of the Company.
  • Maintain Regulatory awareness and changes in regulatory environment. Communicate any regulatory issues and/or information as deemed necessary by Regulatory Affairs or requested by other departments/individuals.
  • Advise and train Cosette’s employees on latest regulatory requirements including all updates/changes and recommend appropriate actions.
  • Review and approve various documents related to product development, manufacturing and testing.
  • Provides Leadership to Regulatory department. Responsible for training, development of the current Cosette regulatory team, and selection and hiring of new team members.
Qualifications:
  • BA/MA degree in Science or Related Field
  • Regulatory Affairs Certification Highly Desirable
  • Minimum of 8 years regulatory experience preferably in generic/specialty pharmaceuticals.
  • Minimum of 3 years management experience of regulatory affairs function.
  • Has proven track record of direct dealings with FDA/OGD personnel and participation in FDA sponsored activities and/or initiatives.
  • Experience working with PE/VC Groups preferred.
Functional Knowledge: Thorough understanding of Regulatory submissions’ content and prerequisite activities.

Industry Related Knowledge:
 Thorough understanding and working knowledge of US FDA (Office of Generic Drugs) and its current Regulatory requirements.

Job-Specific Competencies

  • Submission Activities Demonstrate proficiency in meeting corporate objectives with solid adherence to FDA regulations.
  • Manage RA team members in multiple sites. Demonstrate managerial skills required to mentor, develop, retain, and hire top talent in Cosette’s RA team.
  • Regulatory Acumen - Maintain the highest level of Industry knowledge and translate that into meeting all FDA expectations

Equal Opportunity Employment

Providing “equal employment opportunity” is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.