Senior Regulatory Affairs Specialist
A collective energy and ambition. A place where you can make a real difference.
We’re a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
Are you a driven and personable individual looking for a new Regulatory challenge? Do you have experience providing regulatory support to products from concept to launch?
If the answer is yes - then look no further. Church & Dwight UK Ltd have a permanent role for a Senior Regulatory Affairs Specialist to obtain and maintain market authorization for Company’s products, with primary focus on medicinal products, but including other products and corporate projects as assigned.
The Senior Regulatory Affairs Specialist will be responsible to deliver regulatory guidance and support from concept to launch. This position will interpret and apply all relevant regulations, guidelines and UK Legislation and act as liaison between the Company and Health Authorities. The role holder will be responsible for providing senior regulatory support to product development teams throughout the new product development process, including analysis of applicable standards, risk assessment and effective implementation of regulatory plans.
Other responsibilities include:
Obtain and maintain market authorisation for company products, with emphasis on medicinal products.
Represent Regulatory Affairs in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions to meet launch timelines and/or to resolve technical issues.
Provide UK/EU regulatory guidance to C&D design centers in other markets regarding the potential introduction of their products into UK market.
Host and support Technical Dossier external regulatory audits or inspections of C&D UK Ltd.
Act as a regulatory contact to the competent authorities for medicinal products sold in UK and EU for which C&D US is the legal manufacturer. Support other products as assigned.
Evaluate regulatory impact of proposed changes to marketed products and communicates clear actions to maintain product registrations and certifications.
Monitor and communicate regulatory intelligence to assist in the development of business and compliance plans.
Anticipate regulatory obstacles and emerging issues during the product lifecycle and develop solutions.
Assist in the creation, development and implementation of departmental SOPs.
Independently manage multiple projects, department initiatives and day-to-day tasks.
The cross functional nature of our organisation means that the Senior Regulatory Affairs Specialist will need to build excellent relationships with internal stakeholders including R&D and Marketing to ensure products meet the regulatory requirements for our markets.
The ideal candidate will have extensive experience within a regulatory role in a similar industry and working knowledge of EU and UK post-Brexit legislation.
The person will have strong working knowledge of the medicinal products regulations; knowledge or experience in other category regulations (e.g., medical device, cosmetic, food supplement, detergent, and general consumer products is a significant plus. Finally, due to the nature of the role, excellent verbal and written communication skills are essential.
In return, we offer a competitive salary with 24 days annual leave, performance-related bonus, health cash plan and highly competitive pension scheme.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.co.uk/
When applying for a role and sending your cv, you understand that the Company will hold your personal data in relation to your prospective employment and will process that data for legitimate business reasons within the requirements of UK data protection laws currently in effect and as they become applicable, including the Data Protection Act 1998, the General Data Protection Regulation (Regulation (EU) 2016/679)) and any successor legislation. Candidate Privacy Notice.
DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to firstname.lastname@example.org. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to email@example.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More