Regulatory Affairs Manager

Job Description:

Hello. We're (COMPANY NAME). A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Alvedon, Voltaren, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.

This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

About the role

The Regulatory Affairs Manager Nordics is responsible for the Nordic Regulatory Affairs OHC/VMS Group. This role will ensure proactive and timely compliance with all Nordic and European legislation while ensuring that all regulatory activity is in line with the requirements of the commercial plan. This position offers a great opportunity to proactively seek innovative and rapid path to market for food supplements, medical device, cosmetics and medicines.

This is a great opportunity for a Regulatory Affairs Manager based in Stockholm who will leverage regulatory expertise with real business impact for market leading products and coach a team with two

Key Responsibilities

* Commercial Plan Support: Overall responsibility to ensure that all members of the group support the commercial business plan by provision of an effective regulatory service to allow (COMPANY NAME)'s products to be legally sold in Nordics with strong claims which can be supported. The Regulatory Manager is accountable to update the Marketing Managers and Directors for delivery regulatory requirements in accordance with the commercial plan.

* Compliance: Manage compliance within food supplements, medical device, cosmetics and medicinal products in line with (COMPANY NAME) expectations - support key processes and ways of working (e.g. in relation to CMC, quality, product labelling requirements, artworks as well as local authority regulations)

* Regulatory Strategy: Responsibility to ensure that regulatory strategy is well defined, communicated and implemented and that the Nordic business is protected. It's required to have expert knowledge of all relevant legislation.

* Advertising/Pack Copy approval: Responsibility for compliance of all new pack copy. Provide advice, recommendations, and support for product claims, copy and labelling. Responsibility to challenge all competitors' claims in advertising and to defend all Nordic promotional copy approved in the event of a competitor challenge.

* Stakeholder management: Build strong relationships with internal stakeholders such as; Business, Category, factories, GMS, Quality, R&D and central regulatory group. In this role, the Regulatory manager is responsible for ensuring communication with the Regulatory team and stakeholders for regulatory related updates, roadblocks or issues

* Administration and Training: To be responsible for ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed. Identifies, challenges, develops and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement/simplification.

* Responsibilities: In the absence of Regulatory Lead Nordics to represent the regulatory function in senior meetings and provide regulatory advice and strategy to senior management on OHC/VMS.

* Team leading: Build a high performing team and provide needed trainings for the team members. This position has two direct reports and is accountable for planning the team's work and help them set priorities to meet the objectives. This role will also focus on producing high quality regulatory documents while keeping all files and databases updated together with the team.

Qualifications and skills

Essential

* Degree in Pharmacy, Chemistry or Life Science.
* Experience in Regulatory Affairs, including regulatory experience with either cosmetics, medical devices or food supplements.
* Strong organisational and planning ability to organise and prioritise a high volume of work, so as to ensure that all regulatory activities meet business targets.
* Strong customer focus and good team player who has the ability to work with a large group of people.
* An excellent communicator who ensures that marketing expectations are met with ongoing communication. Also, the ability to train and coach regulatory staff and the ability to impart regulatory knowledge to administrator and marketing team members of all levels.
* An in-depth knowledge of the advertising codes and labelling guidelines is essential.

Preferred

* High learning agility and has the ability and willingness to deal effectively with first-time situations or changing conditions.
* Self-reliant, flexible, with good time management skills with ability to operate in an empowered environment with limited guidance.
* Be able to demonstrate highly effective oral and written communication skills at all times. Capable of delivering key communications with clarity, impact and passion.
* Prioritises work to remain focused on objectives in rapidly changing circumstances.
* Ability to identify and clarify problems for assigned tasks and implement appropriate solutions.
* Team player and ability to work in a matrix environment.
* Demonstrates the flexibility to manage multiple projects in complex virtual /global environments and ability to work within cross-functional teams.
* Track record of delivery against objectives and deliverables.
* Strong leadership skills with proven ability to influence, network and negotiate with key internal / external stakeholders.
* Fluent in at least one of the Nordic languages and based in Stockholm, Sweden.

Care to join us. Find out what life at (COMPANY NAME) is really like www.(COMPANY NAME).com/careers/

At (COMPANY NAME) we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

(COMPANY NAME) is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements