Job Description

Description :Regulatory Affairs Lead assumes responsibilities within the Scientific Affairs team to ensure the timely approval and regulatory maintenance of pharmaceutical products in the assigned territory and participates in various regulatory projects with Pharmascience's corporate partners.RESPONSABILITIES & DUTIES

• Responsible for leading and effectively managing the regulatory activities ensuring competitive approvals and maintenance of products in the assigned territory;
• Responsible for the preparation and lifecycle management of regulatory submissions, ensuring that they are accurately presented, scientifically sound and encompass all relevant material necessary for a complete submission;
• Coordinate with functional teams (R&D, Global Operations, QA/QC, Legal, Bio-pharmaceutics and Project Management) in the compilation of regulatory documents and scientific studies required in the scope of submission;
• Manage strategy for responses to regulatory agency queries, ensuring corporate responses and commitments to authorities are proactively managed, as well as supporting the regulatory needs of the business unit to ensure corporate objectives are met;
• Responsible for monitoring the external regulatory environment, providing proactive regulatory advice and expertise to other groups on a global basis and developing effective regulatory strategies for assigned project(s) in line with corporate objectives;
• Act as a liaison with external regulatory bodies/partners/clients, as required, to ensure appropriate regulatory guidance is given to the R&D teams;
• Develop and strengthen relationships with regulatory authorities in the assigned territory;
• Responsible for the information maintenance in regulatory database, assuring visibility to the international business unit of planned regulatory approvals;
• Participate in product due diligence and development of regulatory strategies;
• Participate in business case preparation (technical scope) in close collaboration with international business unit.

EXPxc3x89RIENCE / EXPERIENCE

• Minimum 10 years pharmaceutical regulatory experience in the assigned territory or similar territory.
• Experience with Pharmascience International Key Markets would be an asset.
• Good understanding of ICH guidelines, CTD requirements, pharmacopeias.
• Solid scientific knowledge.
• Good project and people management skills.
• Good knowledge of drug development process is an asset.
• Proven track record in successfully finalizing registration procedures and regulatory projects for generic products.

HABILETxc3x89S, CONNAISSANCES & APTITUDES / SKILLS, KNOWLEDGE & ABILITIES

• Strong critical thinking ability, communication (written, oral & presentation) and interpersonal skills.
• Strong understanding of international regulatory submission process for generic pharmaceutical products (work experience with innovative products, medical devices or cosmetics would be an asset).
• Excellent working knowledge and understanding of ICH guidelines, with the ability to interpret and apply them.
• Excellent understanding of the drug development process is required.
• Demonstrated ability to work both independently and as part of a multidisciplinary team with a high level of initiative.
• Ability to prioritize and work on multiple projects simultaneously.
• Ability to manage stressful situations and work under pressure.
• Strong understanding of various business models, including but not limited to in-licensing, out-licensing, dossier sales, and supply.
• Experienced in CTD/eCTD submission preparation.
• The candidate must demonstrate good interpersonal skills that will allow him/her to effectively function in a fast-paced, people oriented, team environment.
• Demonstrate proficiency un using Microsoft Suite (Including Word, Excel, and Power-Point) and Adobe.
• English, French (written & spoken), required to work with regulatory authorities located outside the province of Quebec.

Education : Bachelor

Pharmascience