Marcan:·
Marcan Pharmaceuticals Inc., is a Canadian founded company located in the nation’s capital of Ottawa. Acquired by Emcure Pharmaceuticals Ltd., in 2015, Marcan continues to operate under the vision to develop, manufacture & supply affordable, high quality finished dose generics in the Canadian marketplace through both established portfolio offerings as well as new vertically integrated manufacturing capabilities.
Hospital & Institutional:·
The Hospital & Institutional business unit at Marcan Pharmaceuticals is one of four main commercial pillars. The unit provides over 150 SKUs of pharmaceutical product to over 1,200 hospitals in Canada in addition to other specialty markets. As one of the fastest growing divisions at Marcan, the Hospital & Institutional business unit is a key focus of company growth into the foreseeable future.
Your role:·
Reporting to the Vice President, Hospital & Institutional, the Bilingual Sales Associate will operate as a fundamental commercial and operations conduit for the Canadian Hospital & Institutional business pillar. This hybrid role will require bilingual commercial sales expertise in addition to strong strategic analytical capabilities.
Job Responsibilities:
You are someone who has:·
- Bilingual (English & French)
- Bachelor’s degree in Business Administration, Economics or related discipline (MBA preferred)
- Excellent oral and written communication skills, ability to describe problems to others, to listen and to manage and influence stakeholders
- Strong quantitative skills; advanced knowledge in MS Office 365,especially MS Excel
- Excellent attention to detail; Ability to apply logical and evaluative thinking to problem identification and resolution; Ability to multi-task
Travel: 15%
COVID-19 considerations:
We are respecting all Covid-19 recommendations made by the Government of Ontario as well as daily disinfection of the office. Masks are mandatory.
We are an equal opportunity employer and welcome applications from all interested parties. We thank you for your interest, however, only those candidates selected for an interview will be contacted.
Regulatory Affairs Specialist
Position: Full-time Permanent in-person position based in Ottawa
Education: A bachelor’s or master’s degree in health economics, Life Sciences, Pharmacy, Public Health or related field.
Experience: Minimum 5-7 years’ experience within pharmaceutical industry for regulated market dossiers compilation and Lifecycle management.
Duties and Responsibilities:
- Assist with planning, preparing, coordinating, compiling, reviewing and submitting regulatory dossiers (NDS, ANDS, SANDS, Level III changes) to Health Canada - Prepare responses to Health Canada clarification requests in timely manner throughout the submission lifecycle
- Support regulatory strategy development for new product filings and lifecycle management.
- Maintain current drug product registrations and support post-approval regulatory activities.
- Review change controls and assess impact of regulatory updates and support implementation of necessary changes.
- Track submission milestones and post-approval commitments.
- Support product launch activities from a regulatory perspective.
- Work closely with departments including Quality, R&D, marketing, Supply chain·
- Represent the company in industry associations and policy discussions.
- Contact customers and suppliers to obtain data for the submissions.
- Prepare and submit initial, renewal, and amendment applications for Drug Establishment Licenses(DEL).
- Maintain accurate records of all EL-related documentation, including inspection reports, correspondence, and application forms.
Knowledge, Skills and Abilities:
- Familiarity with ICH and Health Canada regulatory Guidelines and submission processes (including chemistry and manufacturing, labeling and administrative requirements)·
- Ability to interpret regulations and create compliant documentation.
- Strong interpersonal, written and verbal skills.
- Excellent organizational and time-management abilities to adhere to submission timelines·
- Comfortable working on multiple priorities and deadlines·
- High attention to detail and accuracy·
- Collaborative and adaptive in fast-paced environments·
- Knowledge of GMP requirements and QA/QC procedures·
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat and eCTD software
Potential Candidates can apply through email HR@marcanpharma.com stating job title in the subject line.