The Director is responsible for (1) proposing or evaluating proposals from other senior company staff for strategies to maximize probability of regulatory approval of ApoPharma’s submissions in worldwide jurisdictions, balancing risks and timelines, and (2) directing the tactical and operational activities of a team of regulatory professionals to support Company and Divisional goals for submissions relating to new and existing products, maintenance of registrations worldwide, and resolution of issues with regulatory agencies to expedite approval. The Director is the primary point of contact with regulatory agencies with respect to product submission and approval processes. Working with the Executive and in a multidisciplinary project environment, the role also requires strong participation in the overall strategic planning and integration of new drug development within ApoPharma.
The Regulatory Affairs (RA) Division is responsible for the management of the first and subsequent regulatory submissions aimed at gaining marketing approval for ApoPharma products worldwide, and for activities relating to maintenance, enhancement, and elective and mandatory amendment of registration in the relevant territories. The RA team provides technical and regulatory advice, support and service to ApoPharma’s internal customers in clinical, non-clinical, marketing, QA and project management areas and to other departments within the Apotex Group of companies that contribute to ApoPharma’s drug development activities. RA also liaises with external customers (e.g. local distributors, contract research organizations and consultants) in the development of effective regulatory strategies and high quality documents to ensure fast approval of ApoPharma products in global jurisdictions.
- Overall direction of the staff, resources, facilities and budget of the RA Division.
- Plans, organizes and coordinates the regulatory activities of ApoPharma through the preparation, review, and follow-up of all submissions filed with all targeted regulatory authorities, including particularly FDA, EMA and TPD.
- Initiates as required, and leads, the planning and coordination of strategic Divisional programs for the progression of new products from initial filing (typically IND or CTA) to final regulatory approval.
- Ensures that appropriate regulatory affairs systems are in place to support efficient and effective submission of all regulatory filings, to monitor the regulatory status of existing products, and to minimize issues arising with regard to regulatory compliance in worldwide jurisdictions.
- Assesses the regulatory acceptability and impact of scientific data and documents generated by ApoPharma, recognizing the significance of findings and their methods of presentation; alerts the company Executive in a timely manner.
- Negotiates on behalf of ApoPharma with regulatory authorities, including formulating responses to questions and comments resulting from agency review of submitted information.
- Ensures that departmental budgets, work plans and schedules are developed, and monitors, optimizes and reports on adherence to them.
- Acts as departmental representative on multidisciplinary drug development projects and/or assigns RA staff to such projects.
- Maintains up-to-date awareness of worldwide regulations and the regulatory environment.
- Advises internal and external customers in areas of regulatory expertise.
- Coordinates appropriate aspects of due diligence for drug candidate in-licensing activities and of preparation of out-licensing packages; recommends courses of action to senior management.
- Leads or contributes to broader activities relevant to the strategies, direction and operations of ApoPharma, including strategic planning, process engineering, GxP inspection readiness, and others as required.
- Carries out additional duties to support ApoPharma generally, as required.
- Performs all work in accordance with the Corporate Values adopted by the Apotex group of companies.
- Ensures compliance with cGxPs as they relate to performance of direct reports, including, but not limited to:
- Ensuring that Job Descriptions are reviewed, signed and sent to Employee Services, annually;
- Reviewing and updating development plans, and ensuring that they are trained and qualified to execute their duties.
- Ensures compliance of team members with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
- An advanced degree (e.g., PhD) or managerial & technical professional qualifications deemed to be equivalent, with a minimum of 7-10 years in management of pharmaceutical regulatory affairs.
- In-depth know-how to operate in the US, European and Canadian regulatory environments, gained through formal and informal interaction with key regulators as well as from detailed knowledge of relevant guidelines and policy documents.
- Demonstrated application of negotiating and reasoning skills with first-tier regulatory agencies to achieve successful outcomes.
- Substantial and demonstrable prior experience of originating and directing regulatory submission strategies.
- Excellent oral and written communication abilities; able to interact effectively with both internal and external bodies. Experience and confidence in managing senior staff (peers and Executives) to meet common time and quality goals.
- Understand key aspects of contributions to submissions of scientific and medical disciplines sufficiently to propose, optimize and, where necessary, question, broad formats and approaches to fulfilling regulatory targets.
- Excellent leadership, organizational, managerial and interpersonal skills; capable of working efficiently within a complex environment.
- Creative problem-solving skills with an ability to identify solutions to problems under critical deadline constraints.