Job Title: Regulatory Affairs Manager - Medicinal Products

Công ty TNHH Colgate Palmolive Viet Nam

Địa điểm làm việc: Hồ Chí Minh

Hết hạn: 05/02/2021

Chi tiết công việc
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No Relocation Assistance Offered
# 107923 - Therwil, Switzerland, Switzerland

Job Title: Regulatory Affairs Manager - Medicinal Products & Food supplements

Location: Switzerland (Therwil)

Reporting: This position reports to the Regulatory Affairs Manager/Leader responsible for Oral Care

Direct Reports: None

Travel: <10%

Responsibilities:

Ensure that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholders.

Ensure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the products under his/her responsibility.

Support in the provision of expert regulatory input to strategic decision making.
Write comprehensible, clear Regulatory Assessments and documents for internal and external stakeholders (eg. Authorities and trade Associations).

Ensure that regulatory submissions and other deliverables meet strict deadlines and fulfill European regulatory standards.

Keep up-to-date with changes in regulatory legislation and guidelines.

Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department.

Establish strong relationships within the European Division, Regulatory Operations and Global Partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, R&D, Regulatory and Product Safety, to ensure alignment and synchronization between Regulatory strategies and Business goals.
Provide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the Regulatory Affairs Managers in the hubs in topics related to the products and projects under his/her responsibility.
Provide assistance to authority inspections in the matters under Regulatory responsibility.
Ensure the review and approval of artworks and ingredient lists for products and regions under his/her responsibility.
Provide input for budget preparation and reviews.
Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her (eg. implementation of new IT systems, review and update of SOPs, etc).
Contribute to an effective use of the network of regulatory consultants, including coordination with procurement and legal for contract negotiations and FCPA and Due Diligence processes.

Competencies Required:

Degree in a relevant scientific discipline (minimum BSc or equivalent, preferably with an MSc)
Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of medicinal products and the technical file (and ideally also medical devices, or other complex legislations)
Good analytical skills and technical/ scientific competence
Strong organizational skills
Attention to details and ability to appropriately assess the regulatory impact and formulate actionable strategy, including taking "the big picture" view on various options
Team player, proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
Fluent in English and another European language

Planning/Priority Setting:

Monitors progress and adapts plans according to change in circumstances
Strong analytical skills with the ability to interpret and present complex data sets

Results Oriented:

Demonstrates high energy in tackling challenging goals
Executes with speed and quality

Communicates Effectively:

Keeps people well informed of plans, goals and objectives
Shares information openly & Capable to handle multi-channel communication simultaneously

Managing Ambiguity:

Ability to think laterally, innovate and adapt quickly to new demands and challenges

Networking and Collaboration:

Develops strong working relationships with internal as well as external stakeholders
Seeks best practice across the company

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognised brand names as Colgate, Palmolive, elmex, Tom's of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet.

For more information about Colgate's global business, visit the Company's web site at [protected info] To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit [protected info] To learn more about Hill's and the Hill's Food, Shelter & Love program please visit [protected info] To learn more about Tom's of Maine please visit [protected info]

Reasonable accommodation during the application process is available for persons with disabilities. Please contact [protected info] with the subject "Accommodation Request" should you require accommodation.