Wearehiring at Cadila Pharmaceuticals Ltd.

Job Role: Regulatory Affairs (US Market)

Job Location: Dholka, Ahmedabad, Gujarat

Experience require: Minimum 6 Years

Key Deliverables of the Role:

Compilation, review and submission of registration dossiers in the regions of US.

Handling of regulatory queries/deficiencies.

Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.

eCTD software handling for ANDA/IND submission, query response and post approval submission.

Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.

Review of Analytical method validation / verification / transfer reports.

Review of DMF and its notifications.

Review and approval of Change Controls & Deviations.

Creation and Maintenance of Regulatory Database for all the submissions.

Tracking of Regulatory Guidance Documents at the respective websites.

Imparting training across the team on new guidance documents.

Interested Candidate can share your CV

on disha.bhalani@cadilapharma.com

Regulatory Affairs in the Pharmaceutical Industry

Regulatory Affairs (RA) is a crucial department in the pharmaceutical industry responsible for ensuring compliance with global regulatory requirements set by agencies like the FDA (USA), EMA (Europe), MHRA (UK), TGA (Australia), WHO, and CDSCO (India). The RA department plays a vital role in obtaining approvals for drug manufacturing, marketing, and distribution while ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).

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Key Responsibilities of Regulatory Affairs:

1. Drug Development & Approval Process

• Guides drug discovery and development to align with regulatory requirements.
• Assists in clinical trial applications (CTA/IND) and marketing authorization applications (MAA/NDA/BLA).
• Works closely with R&D, Quality Assurance (QA), and Production to ensure compliance.

2. Regulatory Submissions & Documentation

• Prepares and submits regulatory dossiers, including:
  • Investigational New Drug (IND) application.
  • New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for generic drugs.
  • Biologics License Application (BLA) for biologic products.
  • Common Technical Document (CTD/eCTD) for global submissions.

3. Compliance with Global Regulatory Agencies

• Ensures pharmaceutical products meet country-specific regulations.
• Maintains compliance with agencies like:
  • FDA (Food and Drug Administration, USA)
  • EMA (European Medicines Agency, EU)
  • MHRA (Medicines and Healthcare products Regulatory Agency, UK)
  • TGA (Therapeutic Goods Administration, Australia)
  • CDSCO (Central Drugs Standard Control Organization, India)
  • WHO (World Health Organization)

4. Labeling & Packaging Compliance

• Ensures drug labels, patient leaflets, and packaging meet legal and safety requirements.
• Reviews barcodes, batch numbers, expiry dates, and storage conditions.
• Aligns with FDA’s Drug Facts Label (DFL) and other international guidelines.

5. Post-Marketing Surveillance & Pharmacovigilance

• Monitors drug safety after market approval (Phase IV Clinical Trials).
• Reports adverse drug reactions (ADRs) and unexpected side effects to regulatory agencies.
• Ensures timely renewals, variations, and safety updates.

6. Regulatory Intelligence & Strategy

• Tracks evolving regulatory changes and guidelines worldwide.
• Provides strategic advice to management on regulatory risks and compliance.
• Assists in patent protection, exclusivity periods, and generic drug approvals.

7. Audits, Inspections, and Compliance Support

• Prepares for regulatory inspections (FDA, EMA, WHO, etc.).
• Ensures compliance with GMP, GCP, and GLP standards.
• Coordinates with Quality Assurance (QA) to meet audit expectations.

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Importance of Regulatory Affairs in Pharmaceuticals

• Ensures legal and ethical approval of drugs before market release.
• Prevents non-compliance penalties, recalls, and market withdrawals.
• Protects public health by ensuring medicines are safe, effective, and high quality.
• Facilitates global market expansion by obtaining international approvals.

Would you like details on Good Manufacturing Practices (GMP) or regulatory submission processes

Location Ahmedabad

Work Exp - 5 to 7 years / CTC - Up to 8.00 LPA

2. Sr Executive / Officer - Regulatory affairs

Work Exp - 3 to 5 years / CTC - Up to 5.00 LPA

Work Exp - 1 to 3 years / CTC - Up to 3.00 LPA

Qualification - B.Pharma / M.Pharma / MBA

Mail id - medipharma.resume@gmail.com / 7201083211

hiring for Regulatory Affairs Specialist for Pune location.

Bachelors degree in a software, technical, or biomedical discipline

Minimum of 2-4 years of Experience in medical device regulated environment.

Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide

Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations

Experience in supporting international registrations (FDA) and clinical investigations (preference) Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference) Knowledge of the NMPA requirements. (preference) Excellent verbal and written communication skills

(English) Enthusiastic, self-motivated regulatory professional Good communicator and team player who can work in a flexible and goal-oriented environment

Structured way of working

Problem-solving and time management skills

Please apply via Referral link: https://lnkd.in/dk9XQS4t

APISYN HEALTHCARE PVT. LTD.

ApiSyn has rapidly evolved into a leading API (Active Pharmaceutical Ingredient) research-based company, offering a comprehensive suite of services and products to pharmaceutical companies globally. ApiSyn exemplifies excellence in custom synthesis, process development, and manufacturing with commitment to innovation, quality, and sustainability.

Date: 16-02-25 Sunday |

Time: 09:30 AM to 04:30 PM

Venue: BARODA PRODUCTIVITY COUNCIL,

2nd Floor, Productivity House, BPC Rd, Alkapuri, Vadodara, Gujarat 390007

Officer/Executive/Sr. Executive-1 to 6 years exp.

Operator-1 to 2 years (API Operations)

Officer/Executive - 2 to 8 years (HPLC, GC & documentation)

Officer/Executive/Sr. Executive - 2 to 8 years (QMS, Validation, Qualification, Compliance)

Trainee/Officer 0 to 2 years

Officer - 1 to 3 years (API Warehouse)

Sr. Executive/Executive- 3 to 7 years (Plant Maintenance, Boiler, Chiller, Utility, RO) Operator-1 to 3 years (Boiler, Chiller, RO, Utility

Executive/Sr. Executive/Ass. Manager -4 to 8 years (DMF & API compilation and submission)

-Carry your updated CV and relevant documents

-Experience in regulatory approved API manufacturing is mandatory for all departments.

-Through knowledge on cGMP norms.

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

The Company:

ALASTIN Skincare, Inc. is the fastest-growing physician-dispensed skincare company in the U.S. with innovative, scientifically proven and clinically tested products. Founded in 2015 and located in Carlsbad, CA, the company provides a comprehensive collection of cutting-edge products for optimal procedure results and daily skincare regimens. Following our recent acquisition by Galderma, the world’s largest independent dermatology company, Alastin has continued its rapid growth operating as an independent business unit of Galderma

Position Summary:
The Quality Assurance and Regulatory Compliance Manager is responsible for product quality, manufacturing compliance, customer claims, vendor audits, safety SOPs, and continuous quality improvement process to meet higher quality standards and achieve customer expectations. This position will inspect products, vendors, processes and procedures to ensure consistency and compliance. This position will report to the Associate Director, Quality Assurance & Regulatory Compliance.

Responsibilities:

• Oversee product quality and packaging specifications, review inspection reports, and support in-house production quality compliance assemblies
• Review cGMP documents to ensure compliance
• Manage and review QA performance data regularly, as well as product statistical reports, present and suggest actions to management
• Oversee testing procedures to ensure that products comply with set specifications
• Batch records review and creation of Certificate of Conformity.
• Write and implement Standard Operating Procedures
• Manage and implement document change controls
• Manage deviation control process
• Train and support QA team on quality procedures, protocols, and documentation
• Communicate quality concerns to management
• Coordinate investigation of quality issues with customers and suppliers
• Review, approve and communicate root cause and corrective action to stakeholders regarding quality issues

Requirements

• 5 or more years of experience in QA/Regulatory management required
• 3 or more years of experience in cGMP/FDA/ISO and regulated OTC products
• Experience in Health & Beauty industry is preferred
• BA/BS degree required, or equivalent education and directly related years of experience.
• Cosmetic ingredient and regulations knowledge
• Thorough knowledge of quality assurance and standards, methodologies
• Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts
• Ability to think strategically and be extremely detail oriented
• Demonstrated ability to work in a team oriented, collaborative environment
• Ability to multi-task, prioritize, and manage time effectively.
• Effective goal setting, budgeting, planning and analyzing information and metrics, relationship-building, and strong problem-solving skills
• Experience working with NetSuite, or other ERP system, order entry portal, or CRM system
• Experience working with eQMS systems (TrackWise etc.)
• Proficient in Microsoft PowerPoint, Word, and Excel
• Ability to work cross-functionally with other departments with the ability to manage upwards and downwards

Physical Requirements:

• Must be able to remain in a stationary position for long periods of time
• The person in this position needs to occasionally stoop, bend, and kneel
• Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer
• Ability to consistently lift/move inventory in excess of 50 pounds.
• Must be able to perform the physical tasks required by the position

Employer’s Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Plant - Regulatory

Department - QC Officer

Qualifications - B.pharma, B.sc, Diploma, ITI

Experience - 2 to 4 yrs

Department - QC or Production Apprenticeship

Qualifications - B.pharma, D.Pharma, B.sc, Diploma, ITI

Experience - 0 to 0 yrs

Department - Production packing Cartonator Operator

Qualifications - B.sc, Diploma, ITI, 12th

Experience - 1 to 3 yrs

Candidate must have exposure of Formulation

interested candidates can share their resume on E- shivendrav.singh@ipca.com