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Job Details
This role is in support of Almus & Alvita, a Cencora business offering a trusted source of generic pharmaceuticals and a line of quality healthcare products in Europe.
We are looking for a skilled Regulatory Affairs Manager to join our Commercial Affairs team!
This is a hybrid position that requires working 3 days in the office, while offering the flexibility to work 2 days from home.
JOB CONTEXT
Alvita is a range of healthcare products, (medical devices, toiletries and biocides etc.) which includes over 700 Alvita products marketed in 7 markets , with plans for further potential expansion. The Alvita range is supplied by over 25 suppliers located in 20 different countries.
The Alvita brand has been identified as a key company growth initiative, with a 5-year plan targeting 2.5 x growth of current revenue and doubling of profit. Over half of the targeted growth will come from New Product Development (NPD) launches. This role will be integral in delivering the NPD required to support the growth plan.
Almus is the generic brand of medicines which includes over 800 products marketed in 4 countries. An Almus entity is either the marketing authorisation holder, Exploitant or own label distributor depending upon the market. The Almus range is supplied by over 35 suppliers located in over 20 different countries.
This senior role sits within the Central Regulatory Team and will work closely with other colleagues within Commercial Affairs; Quality, Sourcing and Supply Chain and local teams in market as well as with suppliers of Alvita and Almus branded products.
JOB PURPOSE
To lead and manage the regulatory activities supporting the own brand ranges sold through the Pharmaceutical wholesale business (Alliance Healthcare) which is part of the Cencora Group, in accordance with budgeted NPD and resourcing plans.
To work in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance, Central team and in market teams, in development and extension of the Alvita product range across the UK and continental Europe and into new potential markets in accordance with agreed budget and 5 year growth plan.
This role will be responsible for leading and performing a variety of regulatory tasks in relation to pharmaceutical and personal care products and in addition provide functional support to regulatory teams in market.
Under the leadership of the European Head of Regulatory Affairs and Pharmacovigilance, this role will be responsible for managing the submission and co-ordinating the necessary variations of European Procedures, involving multiple markets.
This role is pivotal in supporting the development and regulatory maintenance of the Alvita and Almus ranges and potential expansion into new markets, ensuring the own brand products owned by Alliance Healthcare are legally compliant and meet Cencora Group policies and standards.
This role requires someone who is capable of leading the regulatory activities, has excellent organisation skills and attention to detail and able to work on multiple projects and activities simultaneously, whilst being adaptable to changing priorities. Creating effective working relationships with internal and external stakeholders is essential.
Key Responsibilities
Responsible for managing the regulatory tasks in launching multiple NPD (New product Development) projects as part of a multifunctional team, in accordance with the budget and 5 year plans.
Support the European Brand Manager and Central Sourcing Team in assessing potential new Alvita products, the launch in new territories, the evaluation of claims and product attributes of products offered by alternative suppliers.
Review and approve Product Specifications and Artwork Management Sheets (AMS), supporting the launch of new Alvita products and update of existing products. Work collaboratively with other colleagues responsible for originating artwork and provide final approval of artwork for allocated projects.
Assess the regulatory requirements for products ensuring the product and its labelling are legally compliant.
Responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand.
Ensure that Regulatory Intelligence data is maintained and updated according to the relevant processes. Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans. Support the business on regulatory impacting changes, to ensure the necessary steps are taken to mitigate risk to the business.
Manage the preparation and submission of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one market.
Co-ordinate the management of variations with suppliers and local regulatory teams for European Procedures involving more than one market, ensuring all MAs and products in market meet necessary legal compliance.
Manage the preparation and maintenance of Regulatory Compliance Files with the local affiliates and suppliers for European Procedures involving more than one market.
Manage the regulatory information within Samarind RMS for European procedures, involving more than one market.
Contribute as a “key” member of the team responsible for the successful implementation of Identification of Medicinal Products (IDMP) standards into the IT tools and business processes in accordance with legislative deadlines.
Review and approve promotional materials and content on platforms to ensure compliance with relevant legislation and requirements.
Support in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance and the local regulatory teams the development of appropriate global and local SOP’s and working practices, to optimise the effective handling of regulatory tasks related to Alliance Healthcare product portfolio or the development of new processes necessary to deliver compliance with European and local legislation. Provide training as author and or subject matter expert where applicable.
Work collaboratively and build strong working relationships with central and local cross-functional teams to manage the assessment of new products and maintenance of existing products in the Alvita and Almus ranges.
Take a vital role in the Monthly Operational NPD Meetings with the European Business units.
What you'll have
- Degree in life science of science.
- Experience working within European Regulatory Affairs team, supporting pharmaceutical products and or medical devices or cosmetics.
- Competent in managing European Procedures (MRP/DCP’s).
- Good communicator, both orally and in written form.
- Good interpersonal skills. Proven ability to operate within a multifunctional team.
- Analytical, diligent and accurate.
- Excellent organisational skills and ability to prioritise.
- Can do attitude, with strong accountability and ownership.
- Comfortable with a fast pace and switching between competing priorities.
- Fluent English.
- Good knowledge of Microsoft Office.
Specific Skills
- Self-motivated dynamic individual, with the ability and desire to work proactively, with limited supervision.
- Ability to prioritise and organize workload and react to the changing needs o the business.
- Have a proven track record of working effectively under pressure.
- Ability to interpret legislation and evaluate impact on the business.
- Appreciation of the commercial goals of the organisation and the desire to contribute to the successful fulfilment of these goals.
- Proven ability to communicate clearly and logically, both orally and in written form.
Experience
- Knowledge of appropriate European regulations and guidelines within the Medicinal Products, Medical Devices and Cosmetics Industry
- Experienced in submitting new MAA’s for European procedures.
- Experience of medical devices legislation and working on medical device products.
- Good working knowledge of pharmaceutical legislation.
- Additional language skill in addition to fluent English, although not mandatory.
Travel
- Minimal travel - meeting with local regulatory teams may be required.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies: Alliance Healthcare Management Services Limited
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.
