The Director of Regulatory Affairs North America, Pharmaceuticals (FDA) provides leadership for all regulatory activities for FDA pharmaceutical approved products and development projects in support of Merial strategic objectives and in alignment with Business Operations, Industrial Operations, and R&D. The incumbent is responsible for the development and implementation of registration strategies in the area of defense, maintenance and extension of all approved FDA pharmaceutical marketing authorizations and the support and regulatory strategy of development projects for new US pharmaceutical registrations
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Major responsibilities:
- Responsible for lifecycle management of licensed Merial FDA pharmaceutical products and development projects. Provide guidance to professional regulatory affairs experts as required. Promote functional excellence with the goal to foster innovation, optimize time to market and reduce project and portfolio risks.
- Manage official contacts with the US authorities for FDA pharmaceutical products. Maintain open dialogue with FDA contacts and work with the Center for Veterinary Medicine to implement priorities as agreed and in alignment with Merial objectives. Provide representation and point of contact, as assigned, for local, state, and federal regulatory inspections.
- Supervise, develop and implement regulatory strategies necessary to: (1) optimize the position of Merial products in the market by regulatory means; (2) implement manufacturing strategies; and, (3) maintain the products throughout the lifecycle in line with agreed priorities including routine regulatory activities and taking into account the possible future evolution of the regulatory environment.
- Lead communications and liaise with Business Operations, Industrial Operations, and other departments as regulatory strategies are developed and implemented in order to achieve business and manufacturing strategies while accounting for regulatory threats, opportunities, constraints, and future changes.
- Ensure regulatory compliance of licensed Merial FDA pharmaceutical products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, etc. in close collaboration with Industrial Operations, Quality Assurance, R&D, Pharmacovigilance, Business Operations, and others.
- Prepare core regulatory documents for product renewals, variations, country extensions, etc., as required.
- Ensure regulatory compliance of labels by establishing and maintaining the regulatory files for labels and preparing labels and submissions based on applicable regulations in cooperation with Business Operations, Supply, and others as appropriate.
- Define regulatory requirements for projects, as assigned, for incorporation into Development Plans for pharmaceutical projects. Set working priorities within the team and communicate them routinely.
- Serve as a member of interdepartmental project/core teams providing regulatory expertise for assigned projects during the development, registration, and post-approval extension phases of a project
- For assigned projects, identify potential regulatory issues, recommend action, obtain management agreement and execute agreed regulatory strategy.
- Provide input into platform labels for assigned projects and represent agreed regulatory position to interdepartmental project/core teams.
- For assigned projects, prepare core regulatory dossiers for further distribution to other markets as appropriate.
- Manage regulatory submissions and all necessary follow up.
- Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with Merial’s needs.
- Maintain tools (records, schedules, reports, database, etc.) for timely management of regulatory activities.
- Incorporate Merial’s agenda into relevant trade associations and external forums as appropriate. Represent Merial’s interests in trade associations, regulatory forums and other initiatives. Influence activities of these associations in a manner supportive of Merial’s interests. Support Merial safety policies and procedures.
Qualifications
Knowledge and skills:
- Minimum of Bachelor’s Degree in Science (e.g., chemistry, biology); advanced degree strongly preferred (?).
- 10 or more years of experience in the pharmaceutical industry dealing with regulatory issues in particular and related industry matters in general. Experience
interacting with FDA or other government agencies preferred.
- Sound knowledge of the US regulatory requirements and legal framework for pharmaceutical products and of industry trends.
- Experience in other areas of the pharmaceutical industry (particularly at business or manufacturing level) is advantageous.
- Self motivated with demonstrated leadership skills. Record of achievement in area of responsibility and demonstrated success in interactions with regulatory
authorities.
- Excellent communication, interpersonal, negotiation, and organizational skills. Ability to promote innovative solutions on technical issues to the satisfaction
of all concerned functions and agencies within timeframes.
- Working knowledge and experience with common computer software applications.
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