BTG Specialty Pharmaceuticals
Senior Regulatory Affairs Associate
Full Job Description
The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees in 10 countries.
Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.
Our Purpose is supported by our 4 key values:
We make patients our priority
We act with integrity and accountability
We work together as one team
We look for better ways forward
The Senior Regulatory Affairs Associate supports the Global regulatory affairs team with the management of product licenses/registrations within the MENA region, from the initial submission/approval through the product life cycle.
As a Senior Regulatory Affairs Associate, your responsibilities will include:
In collaboration with global regulatory affairs, prepares and compiles market specific files and documents, e.g. application forms, summary sheets, clarification letters, etc.
Prepares new Marketing Authorization dossier
Ensures submitted product documents fully meet the local regulatory requirements for markets of responsibility
As directed by the line manager, executes the agreed plans by submitting the dossier or coordinating the dossier submission via distributors in the respective market, as per planned timelines
In coordination with global regulatory affairs, obtains Drug Regulatory Agencies approval for new product(s)
Supports follow-up with the regulatory authority during submission review and ensures all questions /requests are provided/clarified within due time to ensure timely approval of product.
Executes artwork labelling projects in alignment with the concurrent regulatory applications and safety updates
Support global regulatory affairs projects as needed and expand knowledge in local regulatory affairs management
Liaise with regulatory groups, manufacturing facilities and external contractors to ensure the relevant documentation is available
Responsible for tracking of regulatory commitments
Archiving and maintaining regulatory related records as per local and regional standards
Data entry in relevant systems and ensuring that the data is kept up to date
Performs all assigned responsibilities within assigned projects and ensure that the project is advancing as per committed timelines
Understands the local regulatory guidelines and requirements for the market(s) under their responsibility
Supports the global Regulatory Affairs team on administrative projects
Generate reports, summaries of regulatory data and information for presentations or special regulatory affairs projects
To be successful in this role, you should demonstrate:
Interpersonal and communication skills
Planning & organizational skills
Teamwork, collaboration and stakeholder management
Able to work in multicultural and international environment
Computer literate, e.g. MS Office Skills
Flexible, adaptable and embraces change
Operates ethically with integrity and honesty
Analytical skills and accuracy
Business Communication/Report Writing Skills
Knowledge of Regulatory Affairs
Project Management Skills and Multi-tasking
Professional administrative skills
Good networking skills
Committed to business excellence and continuous improvement
Comply with regulation and standards
S erb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.
To apply for this job please visit ae.indeed.com.