Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Regulatory Project Manager
Major tasks and responsibilities include:
To recommend and devise regulatory strategy, advise line management and seek agreement, then prepare and submit submission for responsible portfolio for extension applications, variation applications and article 61(3) (Directive 2001/83/EC) submissions in order to maintain current portfolio of products on the market compliant with regulatory requirements
In collaboration with Regulatory Assistant ensure that renewal applications and PSURs are prepared and submitted to meet statutory time frames
Complete review of Product Quality Reviews in accordance with regulatory requirements and internal process
Responsibility for product information (label and leaflet), SmPC, VMS review sheets and cosmetic PIF within agreed portfolio, in order to ensure they are maintained to statutory requirements and are fit for purpose by preparing the documents and co-ordinating their internal review and approval
To contribute to the development process by identifying, then recommending (following agreement with line management) regulatory strategy for local projects in order to get new products on to the market in the shortest time by evaluating options and making clear recommendation to line management and then the relevant internal partners, highlighting the potential risks and benefits of the various
To coordinate the preparation of submissions (e.g. marketing authorisation applications (MAA), switch applications, variations) with internal Partners as appropriate, e.g. Marketing, International Regulatory Affairs, R&D and local Quality functions
Support preparation for Health Authority scientific advice meetings when required
Submit MAAs to Health Authority ensuring agreed timeframes are met and all components of submissions meet agreed internal quality standards. Communicate with Regulatory Authorities on the status of applications and respond to and discuss requests for further information
To input into the development of the regulatory strategy and data requirements for global projects where UK and/or Malta are featured as target markets
Provide regulatory support in the preparation of health authority scientific advice meetings
REGULATORY KNOWLEDGE AND INTELLIGENCE:
To keep fully abreast of on-going project activities within the area of product responsibility in order to keep line management aware of all developments (by communicating projects on an ongoing basis as required and via a monthly status report)
To provide regulatory advice to internal partners including Medical, Marketing, Quality, Business Development, International Regulatory Affairs and other R&D functions in order to contribute to development and marketing processes by actively participating in discussions relating to projects
Keep abreast of national and European regulatory requirements relating to the portfolio (medicines, food supplements, cosmetics and medical devices) including legislation, guidelines and best practice.
Review the external regulatory environment and share intelligence with relevant internal parties, understanding and communicating the impact of the information in relation to the CC business
To represent Company interests at local OTC trade association on assigned task force(s) / working group(s) as agreed with line manager in order to derive the full benefits of membership of the association and to share information gained.
Ensuring internal alignment with company position for any task force and provide debrief from such discussions to the regulatory team and other internal partners, as appropriate.
Create and maintain assigned UK Regulatory standard operating procedures to provide
Qualifications, Experience and Skills
- Degree or equivalent in life sciences, chemistry or pharmacy
- Sound knowledge of European regulatory requirements and specifically the UK regulatory environment
- Experience in Regulatory Affairs, with experience in managing projects
- Demonstrable ability to prepare high quality regulatory submissions
- Ability to communicate effectively and assertively with sound negotiating skills.
- Customer focused and team spirited
- The ability to manage several projects at the same time by applying project management skills
- Process driven. Able to make recommendations for improvement to existing processes or construct new processes with input from cross functional groups
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Reward is important to us, employees benefit from excellent employment conditions, such as:
- competitive salary and performance bonus
- 25 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018)
- International career possibilities
- Flexible working
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 432585
Functional Area: Regulatory Affairs