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Regulatory Affairs Specialist
hace 3 meses
Del.
Miguel Hidalgo, Mexico City, Mexico
Position Purpose
This position will coordinate and implement regulatory strategies for Medical Device products (Formulated or Over the Counter) for Mexico, including submissions for product approval to gain market access.
This role will require proactively identifying regulatory requirements and risks for Medical Device products, and developing plans for regulatory submissions.
Additionally, this position will help to maintain product compliance during the whole life-cycle, for any category of products for the Latam regional.
Key Responsibilities:
- Compile documents and information required for high quality and successful submissions, license renewals, annual registrations, and maintenance of Medical Device and Cosmetic product registration dossiers for authorities.
- Assist the preparation of product dossiers regionally, specifically for Medical Device products, as well as ensure accurate archiving of all documents submitted to and received from Proficient Authorities, to accurate data timely and keep update regulatory databases and tools for products to comply.
- Stay abreast of Over the Counter drug products (OTC) and Medical Device regulations and requirements for Mexico and LatAm region.
- Lead process simplification and harmonization activities to improve efficiency within the Regulatory Operations team.
- Assist submission of product dossiers, variations and responses to Competent Authorities, as well as ensure proper electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, to accurate data timely and keep update regulatory databases and tools for assigned products to comply.
- Alert Regional Regulatory Affairs manager of upcoming renewals and commitments in a timely manner.
- Report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
- Keep track of outstanding documentation, notify and advise the manager on a timely manner.
- Update and maintain product registration and ingredients archives, databases and tracking tools.
- Upload and maintain files/dossier databases, as well as any documentation supporting the placing of the market of other categories of products; e.g. Medical Devices, Cosmetics, Home Care, Consumer goods
- Work closely with other regions to obtain the relevant documents and information for product dossiers.
- Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
- Collect appropriate documentation in order to support regulatory submissions in other countries when products are cross border sourced.
Artwork Approval:
- Assist the Regional Regulatory Affairs managers in the creation of ingredient list for labeling purposes
- Assist the RA managers with artwork review and approval.
Regulatory intelligence and product advocacy activities
- Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
- Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and
What do you need for the position?
- BS degree in Pharmacy, Chemical Pharmaceutical or any related area.
- 3/4+ years of confirmed experience in regulatory affairs, managing formulated medical devices or OTC drug products.
- Strong understanding of registration and regulatory requirements of formulated medical devices, pharmaceutical products and cosmetics.
- Fluency in spoken and written Spanish is mandatory.
- Advanced English level.
Nice to have:
- Desirable good knowledge over other medical devices categories as functional aids or supplies for dental use.
- Good skills in Portuguese language is a plus.
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.
Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition.
