Vacancy Detail

Director of Regulatory Affairs


Region: Ireland

Location: Ireland

Salary: Competitive

Ref: 04058

Job Type: Permanent

Posted: 19/11/2018

Back to search

Director of Regulatory Affairs


Role description

Role: Director Regulatory, CMC and Quality
Package: Competitive basic salary 120-150K (Euro)
Location: Head Office - Dublin

Role Type: Director of Regulatory Affairs, Regulatory Affairs

The client is an integrated healthcare company operating in the prescription and OTC market segments with an ambitious growth plan across a range of pharmaceutical activities
The Role:
The Directory of Regulatory will be responsible for all matters pertaining to the Regulatory function within the company and all external interactions, including, but not limited to authorities, bodies, partners, development and manufacturing and development companies. To be the Responsible Person and to manage all Quality related matters pertaining to the company and its products. To be the internal owner and to communicate internally all relevant issues, objectives and opportunities and to be responsible for delivering change. To ensure the company abides by all relevant rules and regulations. To be an active member of the company management team, inputting from a technical and business perspective and to work to help the company deliver growth across the current and future portfolio.

Key Accountabilities will include:
Provide recommendations to the Project Team and/or Management on regulatory direction for development projects and approved products for incorporation into the development strategy.
Establish and maintain regular and effective interface with regulatory officials and other authorities.
Determine strategy for submissions/ change of registration documents and extensions.
Responsible for the timely reviews of all relevant regulatory projects and documents relating to development programmes.
Lead meetings/teleconferences with regulatory authorities and external companies and assure that the outcomes of are clearly documented, understood and agreed upon by all participants.
Identify and clearly communicate all regulatory, CMC and quality issues related to projects and Products to the Management Team.
Maintain current working knowledge of global relevant regulatory, CMS and quality requirements.
Lead meetings updating status of regulatory activities and contribute to the establishment of regulatory strategies for new products and processes.
Provide guidance to peers regarding regulatory, CMS and quality issues.
This role reports to the COO/ CEO and will manage regulatory direct reports. Regular contacts including Quality, Logistics, Marketing, R&D, Site Production Leaders as prime consultant and external spokesperson for the organization on highly significant matters relating to policies programs, capabilities and long-range goals and objectives.


Qualifications

Life science degree. Ph.D in a Scientific discipline, preferred.

Person experience required

Must have 8-10 years pharmaceutical industry experience in Regulatory Affairs (small and large molecule experience a plus) across specialist and standard product areas Experience presenting to Regulatory Authorities on behalf of Company Solid knowledge of: drug development; EMEA and ICH guidelines and regulations Previous direct experience with development programs through registration strongly preferred Must have previous experience leading interactions with Health Authorities Strong interpersonal skills and the ability to effectively work with others Experience of working within the Quality function within an international pharmaceutical company and an understanding of the legal and regulatory requirements. Knowledge of and experience managing or being part of pharmacovigilance within an international pharmaceutical company and an understanding of the statutory requirements Solid knowledge of CMC issues through direct experience working with a pharmaceutical company managing at least one Tech Transfer where you were the responsible person Ability to work independently as well as part of a team environment Complete understanding and application of principles, concepts, practices, and standards within discipline. Knowledge of International pharmaceutical manufacturing regulations. Positive attitude, energetic and proactive Proven ability to manage multiple projects, identify and resolve regulatory issues
Apply for role Back to search

Share this page


 Vacancies

Vacancies

 Services

Services

 Contact

Contact

 Send CV

Send CV

© Copyright 2019 Chemistree
Web design by Union 10 Design