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Description
The Associate Regulatory Affairs Director (ARAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned products with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Description
The Associate Regulatory Affairs Director (ARAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned products with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will be accountable to provide regulatory input to Global Program deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
* Developing and implementing global regulatory strategies for assigned products.
* Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
* Providing input to submission strategy and other critical regulatory documents. May represent my client as a point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
* May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
* Ensuring exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.
Qualifications:
* 7+ years of Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
* Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
* Experience providing strategic regulatory advice for the global development of productsthrough all stages of development including marketed assets.
* Successful track record in registering and overseeing regulatory strategies for assets.
* Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
* Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
* Strong interpersonal, and written/verbal communication skills.
* Proven track record practicing sound judgment as it relates to risk assessment
* Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
Education
* Bachelor’s Degree, life science highly desirable
* Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
* Additional certification and/or training relevant to the role over the past
Employee Value Proposition
It's an opportunity to work within a top 10 pharmaceutical company in a global position, hybrid position, lucrative opportunity, and working directly with the head of global regulatory affairs for my client.
Job Title: Associate Regulatory Affairs Director
Location: Dublin, Ireland
Job Type: Contract
Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Quality Assurance, and Project Management
* Industries
Pharmaceutical Manufacturing and Retail Pharmacies
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